WOMEN S INTERAGENCY HIV STUDY ARTERIAL BRACHIAL INDEX SUBSTUDY

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1 A. STUDY PURPOSE WOMEN S INTERAGENCY HIV STUDY ARTERIAL BRACHIAL INDEX SUBSTUDY T measure peripheral arterial disease (PAD) using the ankle brachial index (ABI) in WIHS wmen 40 years f age r lder (i.e., > 40 y) every tw years t determine the factrs assciated with PAD and its prgressin in HIV infected and uninfected wmen. We will als study hw PAD might affect physical functin in wmen wh are participating in the Musculskeletal (MSK) Study, because MSK wmen have detailed measures f limb fat, limb muscle, inflammatry markers and physical functin perfrmed. B. SPECIFIC AIMS Aim 1: T determine the assciatin f HIV and metablic factrs with PAD in HIV infected and HIVuninfected wmen, and t determine the assciatin f HIV related factrs with PAD amng HIVinfected wmen. Aim 2: T examine the assciatin f HIV infectin and PAD with physical functin. C. HYPOTHESES Hypthesis 1a: HIV infectin will be independently assciated with lwer ABI values and increased symptmatic and asymptmatic PAD, after cntrlling fr demgraphic and behaviral factrs. Hypthesis 1b: The assciatin f HIV infectin with lwer ABI values and increased symptmatic and asymptmatic PAD will be nly partially explained by metablic factrs assciated with HIV infectin. Hypthesis 1c: Amng HIV infected wmen, the severity f immunsuppressin and elevatins in markers f inflammatin will be assciated with lwer ABI values and increased symptmatic and asymptmatic PAD after cntrlling fr demgraphic, behaviral, and metablic factrs. Hypthesis 2a: HIV infectin will be assciated with decreased physical functin due t the catablic effects f HIV n muscle mass in the lwer extremities. Hypthesis 2b: Lwer ABI values will be assciated with decreased physical functin due t decreased perfusin f lwer extremity muscles by peripheral arteries. Hypthesis 2c: HIV infectin, sarcpenia, and PAD will be assciated with greater declines in physical functin; PAD and sarcpenia may be mre imprtant predictrs than HIV status itself because the negative effects f HIV infectin n physical functin will be amelirated by effective HAART use. D. RESEARCH DESIGN AND METHODS 1. STUDY DESIGN The prpsed research is a lngitudinal ABI study t begin at WIHS cre visit 39 (Octber 1, 2013). ABI will serve as bth a predictr and an utcme in analyses. Fr studies related t ABI as the utcme (Aim 1), all WIHS participants > 40 years will underg an ABI measurement every tw years (because significant changes frm a nrmal ABI t a lw ABI were demnstrated ver an average f three years in an HIV uninfected chrt). We Sectin 38, Page 1 f 10

2 estimate that if there are 2,500 active wmen that are seen at any given visit and abut 80% are > 40, then we will study 2,000 wmen (apprximately 1,350 HIV infected and 650 HIVuninfected) every tw years. Fr studies related t ABI as the predictr (Aim 2), we will leverage the nging MSK data cllectin which has targeted 330 WIHS participants (apprximately 220 HIV+ and 110 HIVbetween the ages f 40 and 60 years) fr enrllment int MSK frm three WIHS study sites (Brnx, San Francisc, Chicag). The prpsed study will add ABI measurements t all MSK participants at their baseline and tw year fllw up visit (that will be btained either at the WIHS CORE visit r at the MSK visit, if the MSK visit des nt cincide with the every tw year visit prpsed in the entire WIHS chrt > 40 years). Fr wmen wh have already cmpleted their MSK visit, bring back MSK wmen fr ABI measurement if the MSK visit is within ne year f the initiatin f the ABI study, since prgressin f PAD is slw. 2. INCLUSION CRITERIA WIHS wmen 40 years f age r lder (i.e., > 40 y) will be asked t take part in this study. 3. PREDICTOR AND OUTCOME VARIABLES: ABI is calculated as the rati f the highest systlic bld pressure (SBP) in the brachial artery divided by the lwest SBP f either the drsalis pedis r psterir tibial arteries. It is classified int ne f fur categries: Nrmal 1.00 ABI 1.40 Abnrmal ABI < 0.9 Brderline ABI High ABI 1.40 in at least 1 leg (indicates incmpressibility and pssible arterial calcificatin) E. ABI PROTOCOL 1. PREPARATION 1. Make sure t have a full kit cntaining: Niclet ABI Kit (EN5A) Niclet Elite 100 Dppler 5 MHz Prbe Sphygmmanmeter Fur 12 cm (blue cuff) quick discnnect vascular cuffs Tw 16 cm (black cuff) quick discnnect vascular cuffs (Welch Allyn Large Adult # ) Tw 20 cm (black cuff) quick discnnect vascular cuffs (Welch Allyn Thigh Cuff # ) Ultrasund transmissin gel Sectin 38, Page 2 f 10

3 Tissue r wash clth t remve ultrasund cntact gel Nn txic dry erase marker T Spray (Pharmaceutical Innvatins, Inc.) and/r Clrx Disinfecting Wipes 2. If the ABI des nt precede the bld draw, ensure that at least ne hur passes between phlebtmy and the ABI, and that the needle site has cltted. Fr efficiency s sake, it may be best t d the ABI right after BIA has been cmpleted because the participant will already be in a gwn and lying supine n her back. 3. Explain the prcedure t the participant and allw him/her t ask questins. 4. Cnduct the examinatin in a quiet, warm, and cmfrtable rm. If the rm is cl, a blanket may be used t cver the participant (including arms, hands, and feet), except while the actual measurements are being made. 5. Have the participant lie supine n a cmfrtable hrizntal examinatin table. The head and heels must be at the same level, and therefre the table must be lng enugh s that fr each participant, the entire head and bth feet must be n the table, nt verhanging. Because having the feet even slightly lwer than the rest f the bdy will prduce an invalid ABI measurement, an versized examinatin table must be available at the field center fr tall study participants. 6. Arms belw the shulder and legs belw the knee shuld be bare. 7. Inspect all fur bld pressure (BP) cuffs befre placement and use nly cuffs that are clean and dry. D nt place bld pressure cuffs ver any lesin that culd be a ptential surce f cntaminatin. If a lesin is visible that culd be a ptential surce f cntaminatin, then d nt perfrm the measurement in the affected extremity. 8. Have the participant rest quietly fr at least five minutes befre beginning the measurement prcedure. The participant may be sitting r supine while resting. 9. While the participant is resting, place an apprpriate BP cuff arund bth arms, based n arm circumference at midpint. The general rule is that the cuff width must be at least 40% f the arm circumference. The tw cuff sizes shuld be emplyed as fllws: Adult cuff (12 cm blue cuff) fr arm circumference f < 32 cm Large adult (16 cm black cuff) cuff fr arm circumference f cm Thigh (20 cm black cuff ) cuff fr circumference f > 43 cm 10. Place a cuff n each ankle, s that the tube is facing the trs, nt the tes, and the lwer prtin rests 3 cm prximal t the greatest prtuberance f the medial mallelus (ankle bne). Adult sized cuffs (12cm) shuld almst always be able t fit arund the ankles. 11. Once all fur cuffs are in place and the five minutes f resting are cmplete, yu may begin the measurements as described belw. 2. PROCEDURE Befre yu begin the prcedure, instruct the participant t remain relaxed and t refrain frm helping yu (e.g. lifting the arm t facilitate placement f the cuff). Once yu begin the prcedure, explain the steps t the participant as yu prceed. By palpatin, lcate the brachial artery n bth arms (antecubital fssa), and the drsalis pedis Sectin 38, Page 3 f 10

4 (drsum f the ft and ften in direct line with the secnd te) and psterir tibial (medial ankle just behind the medial mallelus) arteries n bth legs. Mark the lcatin f each artery with a marker. Smetimes an arm r ankle pulse will nt be palpable but can be fund with the Dppler. Using the prcedure belw, measure SBPs in the fllwing rder (same as n the frm): 1. Right brachial artery 2. Right drsalis pedis artery (tp f the right ft, in line with the secnd te) 3. Right psterir tibial artery (inside right ankle) 4. Left psterir tibial artery (inside left ankle) 5. Left drsalis pedis artery (tp f the left ft, in line with the secnd te) 6. Left brachial artery Place an apprpriate amunt f ultrasund cnducting gel ver the end f the Dppler. On ccasin, there may be skin lesins n the arms, legs r at the insnatin site that are f cncern fr perfrming the measurement f the SBP. In these instances, ABI shuld nt be assessed in the affected extremity and reasn fr nt calculating ABI shuld be recrded n frm. After palpating the lcatin f the pulse, turn n the Dppler and place the prbe ver the artery. With this large prbe, careful angulatin is nt necessary. Place the prbe in line with the artery and mve it frm side t side until the strngest pulse is heard. Dn t press t hard n the artery with the prbe. Rest yur hand cmfrtably s that the prbe is secured in place nce a strng pulse is heard. Explain the prcedure t the participant and ask if the participant has any questins befre the measurements begin. If applicable, suggest t the participant t rest cmfrtably and t try t be quiet and still. In a small percentage f participants, yu may nt be able t find the psterir tibial r drsalis pedis pulse. If yu are having truble, be patient and cntinue t search fr at least three minutes. If yu are still unable t lcate a pulse, enter a systlic pressure f "000" fr that artery. Inflate the cuff until the pulse is n lnger audible. Inflate t 20 mm Hg abve the level at which the pulse sund disappears. (If the pulse cannt be bliterated, yu may raise pressure t a maximum f 300 mm Hg. If nt bliterated at that pint, recrd 300 ). Deflate the cuff slwly allwing the pressure t drp at a rate f 2 mm Hg per secnd. Recrd the pressure at which the first sustained (mre than ne beat) pulse reappears. This is the SBP at this lcatin. Deflate the cuff cmpletely. Enter the measurement in the apprpriate field n the ABI frm immediately. If a given measurement was nt dne, be sure t list the specific reasn why n the frm. If the signal remains faint as mre pressure is released r if the prbe mves ff the artery, deflate the cuff cmpletely, and then repeat the measurement. After cmpleting the ABI measurements, thrughly clean the Dppler prbe with T Spray r a Clrx Disinfecting Wipe. Please nte that the Dppler must be cmpletely clean and dry between participants. Sectin 38, Page 4 f 10

5 3. CALCULATION OF THE ABI The ABI will be calculated frm yur measurements in the fllwing manner: The ABI denminatr There is nly ne ABI denminatr per participant fr bth the left and right ABIs. This denminatr is the higher arm SBP. The higher f the brachial artery SBP is used t avid ptential bias frm subclavian stensis (which culd lead t a falsely lw SBP). The right ABI numeratr is defined as the higher f (1) the right psterir tibial SBP r (2) the right drsalis pedis SBP. The left ABI numeratr is defined as the higher f (1) the left psterir tibial SBP r (2) the left drsalis pedis SBP. We will als perfrm analysis where the lwest lwer extremity SBP (f either drsalis pedis r psterir tibial) will be used as the numeratr as use f the lwest pressure has been assciated with greater sensitivity in the detectin f subclinical disease. The highest leg SBP is ften used as the numeratr, because a greater sensitivity in detecting ischemic leg pain has been suggested when using the highest leg pressure. The right ABI is the right ABI numeratr divided by the ABI denminatr. The left ABI is the left ABI numeratr divided by the ABI denminatr. F. ABI QA ACTIVITIES 1. FIELD STAFF QUALIFICATIONS N specific qualificatins are necessary. 2. FIELD STAFF TRAINING All technicians will be trained by the primary technician, Heather Freasier. An verview and vide describing the prcedure and the necessary equipment is prvided. Technicians shuld practice the prcedure n vlunteer participants and perfrm the requirements necessary fr certificatin (described in the next sectin). 3. FIELD STAFF CERTIFICATION T becme certified, technicians must Read the ABI prtcl in the Manual f Operatins, Sectin 38. Practice the prcedure accrding t the ABI prtcl n vlunteers as necessary. If a technician has never previusly perfrmed ABI measurements, practice readings are recmmended befre cntinuing with the certificatin prcess. Pass a practical examinatin administered by the central trainer. The practical examinatin invlves perfrming the ABI prcedure n ne vlunteer participant under bservatin f the central trainer and in accrdance with the WIHS Supine ABI Certificatin checklist. As the trainee recrds the pressures, the trainer shuld verify that they are crrect (i.e. the values the trainer wuld have recrded) and cmplete the checklist t dcument that the prcedure is dne accrding t the prtcl. Sectin 38, Page 5 f 10

6 4. MAINTAINING CERTIFICATION T maintain certificatin, each Field Staff technician must Perfrm the ABI prcedure n at least six participants every tw mnths. Repeat the riginal certificatin prcess prir t each new examinatin cycle. 5. QC ACTIVITIES Bld pressure cuffs: Verify that the full range f bld pressure cuff sizes is available. Reprt any missing cuffs t the site Prject Directr immediately. Niclet Dppler apparatus: Check t make sure the batteries fr the Dppler are wrking. Replace batteries as needed. 6. QC MONITORING OF TECHNICIAN QUALITY T insure that technicians cntinue t perfrm the ABI prcedure accrding t the WIHS prtcl, each technician is bserved in the clinic and evaluated accrding t the WIHS ABI Certificatin Checklist by Heather Freasier simultaneus t the Anthrpmetry recertificatin visit. 7. WDMAC QC ACTIVITIES WDMAC peridically analyzes the available baseline bld pressure data and QC replicate data t insure that apprpriate levels f measurement quality are maintained. The fllwing variables are mnitred: Systlic ankle pressures (psterir tibial and drsalis pedis) in bth legs Brachial systlic bld pressure in bth arms Ankle Brachial Index Age and gender adjusted means fr these variables by WIHS site, by technician within WIHS site, and by increments in time are cmputed t examine trends, identify utlying r unusual values, quantify differences between the measurements recrded by different technicians at different WIHS sites, and mnitr measurement drift. Technician and WIHS site specific measures f variability in these measurements will als be examined t assess measurement reliability and detect unusual discrepancies acrss WIHS sites. In additin, the bld pressure measurements btained by each technician are analyzed fr digit preference. 8. QC REPORTING WDMAC and the Metablic/Vascular WG will review results f these analyses and prvide updates t the WIHS site PI s that apprpriate actin can be taken t imprve measurements if needed in a timely fashin. G. SUPPORTING DOCUMENTATION WIHS Supine ABI Certificatin Checklist, adapted frm the MESA Study: Sectin 38, Page 6 f 10

7 DATE: m day year WIHS Supine ABI Certificatin Checklist WIHS site: Technician: Name/ID Central Trainer: Purpse f Evaluatin: Certificatin Site Visit Please check the apprpriate bx if technician perfrmance is satisfactry (r unsatisfactry) fr each line item. Please nte any cmments r remedial actin taken in Cmments sectin if perfrmance was nt satisfactry. General: S U Thrughly explains the prcedure t the participant. Insures that the participant is relaxed and lying cmpletely supine (legs straight and dwn with feet rlled utward) n the examinatin table. Has participant rest quietly fr at least 5 minutes prir t the prcedure. Infrms participant just befre inflating cuff t avid startling the participant. Recrds crrect (i.e. pressure that bserving trainer wuld recrd) pulse bliteratin pressure. Reads all pressure measurements at eye level. Recrds crrect (i.e. pressures that bserving trainer wuld recrd) pressures fr all arteries. Right Brachial Artery: Places bld pressure cuff f apprpriate size ver right brachial artery. Lcates brachial artery by palpatin. Marks the lcatin f the artery with a black marker. Applies ultrasund jelly ver brachial artery. Lcates brachial artery using Dppler prbe. Inflates cuff quickly t at least 20 mm Hg abve maximal pressure. Deflates at 2 mm Hg/secnd until a sustained systlic pressure is audible. Reads (at eye level) and recrds first systlic bld pressure at which a sustained pulse was first audible. Deflates cuff quickly and cmpletely after measurement is btained. Sectin 38, Page 7 f 10

8 Right Drsalis Pedis Artery: 19. Places bld pressure cuff f apprpriate size t right ankle with midpint f bladder ver psterir tibial artery, with lwer end f bladder apprximately 3 cm abve medial mallelus. 20. Lcates right drsalis pedis artery by palpatin. 21. Marks the lcatin f the artery with a black marker. 22. Applies ultrasund jelly ver drsalis pedis artery. 23. Lcates right drsalis pedis artery using Dppler prbe. 24. Inflates cuff quickly t at least 20 mm HG abve maximal pressure. 25. Deflates at 2 mm Hg/secnd until a sustained systlic pressure is audible. 26. Reads (at eye level) and recrds first systlic bld pressure at which a sustained pulse was first audible. 27. Deflates cuff quickly and cmpletely after measurement is btained. Right Psterir Tibial Artery: 28. Lcates right psterir tibial artery by palpatin. 29. Marks the lcatin f the artery with a black marker. 30. Applies ultrasund jelly ver psterir tibial artery. 31. Lcates right psterir tibial artery using Dppler prbe. 32. Inflates cuff quickly t at least 20 mm Hg abve maximal pressure. 33. Deflates cuff at 2 mm Hg/secnd until a sustained systlic pressure is audible. 34. Deflates cuff quickly and cmpletely. 35. Reads (at eye level) and recrds right psterir tibial systlic bld pressure at which a sustained pulse was first audible. Left Psterir Tibial Artery: 36. Lcates left psterir tibial artery by palpatin. 37. Marks the lcatin f the artery with a black marker. 38. Applies ultrasund jelly ver psterir tibial artery. 39. Lcates left psterir tibial artery using Dppler prbe. 40. Inflates cuff quickly t at least 20 mm Hg abve maximal pressure. 41. Deflates at 2 mm Hg/secnd until a sustained systlic pressure is audible. 42. Reads (at eye level) and recrds first systlic bld pressure at which a sustained pulse was first audible. 43. Deflates cuff quickly and cmpletely after measurement is btained. Left Drsalis Pedis Artery: 44. Places bld pressure cuff f apprpriate size n left ankle with midpint f bladder ver psterir tibial artery, with lwer end f bladder apprx. 3 cm abve medial mallelus. 45. Lcates left drsalis pedis artery by palpatin. 46. Marks the lcatin f the artery with a black marker. 47. Applies ultrasund jelly ver drsalis pedis artery. Sectin 38, Page 8 f 10

9 48. Lcates left drsalis pedis artery using Dppler prbe. 49. Inflates cuff quickly t at least 20 mm Hg abve maximal pressure. 50. Deflates at 2 mm Hg/secnd until a sustained systlic pressure is audible. 51. Reads (at eye level) and recrds first systlic bld pressure at which a sustained pulse was first audible. 52. Deflates cuff quickly and cmpletely after measurement is btained. Left Brachial Artery: 53. Places bld pressure cuff f apprpriate size ver left brachial artery. 54. Lcates left brachial artery by palpatin. 55. Marks the lcatin f the artery with a black marker. 56. Applies ultrasund jelly ver brachial artery. 57. Lcates brachial artery using Dppler prbe. 58. Inflates cuff quickly t at least 20 mm Hg abve maximal pressure. 59. Deflates at 2 mm Hg/secnd until a sustained systlic pressure is audible. 60. Reads (at eye level) and recrds first systlic bld pressure at which a sustained pulse was first audible. 61. Deflates cuff quickly and cmpletely after measurement is btained. Cmments: Crrective Actin Taken: Supervisr Site Visitr / Signature Sectin 38, Page 9 f 10

10 H. QUESTIONNAIRE ADMINISTRATION 1. SAN DIEGO CLAUDICATION QUESTIONNAIRE (BRIEF VERSION) The San Dieg Claudicatin Questinnaire (SDCQ) cnsists f 12 questins that determine asymptmatic versus symptmatic lwer extremity PAD (i.e., n pain, atypical pain, and ischemic pain. Questinnaire will be administered at all visits where ABI is dne. 2. PHYSICAL ACTIVITY QUESTIONNAIRE The Physical Activity Questinnaire (PAQ) (adapted frm the FRAM Study and CARDIA) will be administered at all visits where ABI is dne. The same PAQ study has been used at earlier visits as part f ther WIHS substudies and is currently being administered in the MSK Study. Therefre, MSK participants d nt have t repeat the questinnaire if perfrmed at CORE visit. If ABI is nt dne fr any reasn at a visit (e.g., participant is < 40 years ld, bleeding at needle site, etc.), then d nt cmplete either the SDCQ r the PAQ frms. Sectin 38, Page 10 f 10