D M Y Y Y Y D D M M Y Y Y Y. Previous MI (apart from acute PCI) 0=no 1=yes 9=unknown

Transcription

1 I Patient details and Preoperative Data Date of Informed Consent dd-mm-yyyy (Please leave blank if waived by Ethics Committee) Please enter Patient ID in this format xxx-xx-xxx 3 digit code for the country, 2 digit code for the hospital and 3 digit individual patient number, separated with hyphens. Patient ID D D D - D D - D D D Date of birth dd-mm-yyyy Recruitment Date dd-mm-yyyy D M Sex Female Male Details of Percutaneous Coronary Intervention (PCI) Date of most recent PCI dd-mm-yyyy Urgency of PCI 1=acute 2=elective 9=unknown Number of stents deployed Enter number of stents from 0 to 9 99=unknown Type of stents deployed 1=bare metal 2=drug eluting 3=both 9=unknown Cardiovascular Risk Factors Previous MI (apart from acute PCI) 0=no 1=yes 9=unknown Angina 0=no 1=yes 9=unknown Previous CABG 0=no 1=yes 9=unknown Previous CVA 0=no 1=yes 9=unknown D M Y Y Y Y Acute heart failure 0=no 1=yes 9=unknown Left ventricular hypertrophy on ECG or Echo 0= no 1=yes 9=unknown Able to climb one flight of stairs without stopping 0=no 1=yes 9=unknown Left ventricular ejection fraction 1=good, greater than 50%; 2=moderately impaired, 30-49%; 3=severely impaired, less than 30%; 9=unknown Diabetes Mellitus 0=no; 1=diet controlled; 2=oral hypoglycaemic medication; 3=insulin; 9=unknown Creatinine preoperative value. micromoles/litre (leave blank if not available) (indicate units used) /decilitre History of smoking 1=never; 2=discontinued four or more weeks before surgery; 3=current smoker; 9=unknown Preoperative haemoglobin. grammes/decilitre (leave blank if not available) (indicate units used) millimoles/litre Page 1/8

2 II Intraoperative and Postoperative Data Date of surgery dd-mm-yyyy Operation ASA I II III IV V Urgency of surgery elective urgent Surgical specialty (select single most appropriate): Orthopaedic Urological Gynaecological Thoracic Trauma Head and neck Breast Vascular Neurosurgical Hepato-biliary ENT Plastics/Cutaneous Gastro-intestinal Dental Endocrine Eye Other Classify patient operative risk Operative risk: referring to table as guidance but individual procedure may classify differently according to physician judgement. low intermediate high Anaesthetic Technique: 1=general alone; 2=general with neuroaxial blockade; 3=general with plexus block; 4=neuroaxial blockade; 5=plexus block; 6=local infiltration Transfusion of Blood Products (transfusion intraoperatively and 24 hours after surgery) Total number of red cell units transfused during and 24 hours after surgery: (if nothing please enter 0) Total number of fresh frozen plasma/octaplas units transfused during and 24 hours after surgery: (if nothing please enter 0) Total number of platelet units transfused during and 24 hours after surgery: (if nothing please enter 0) Cryoprecipitate given during and 24 hours after surgery: 0=no 1=yes Details of other coagulation factors given during and 24 hours after surgery: (Leave blank if none) Cell salvage used during surgery 0=no 1=yes Volume of cell salvage blood reinfused millilitres (Leave blank if unknown or none) Lowest haemoglobin during and. grammes/decilitre 24 hours after surgery millimoles/decilitre (leave blank if not available) (indicate units used) Page 2/8

3 Bleeding Events (Intraoperative and Postoperative) Reoperation for Bleeding 0=no 1=yes If yes, date of first reoperation for bleeding Gastrointestinal haemorrhage 0=no 1=yes Date of first gastrointestinal haemorrhage Haemorrhagic stroke 0=no 1=yes Date of first haemorrhagic stroke Postoperative spinal or epidural haematoma 0=no 1=yes Date spinal or epidural haematoma diagnosed Postoperative coronary angiography Postoperative coronary angiography 0=no; 1=yes, new changes; 2=yes, no new changes If yes, new changes; choose one of the following: 1=yes, evidence of new in stent coronary thrombosis/stenosis, no intervention 2=yes, evidence of coronary thrombosis/stenosis not in stent, no intervention 3=yes, evidence of new in stent coronary thrombosis/stenosis, new PCI 4=yes, evidence of coronary thrombosis/stenosis not in stent, new PCI If yes, date of postoperative coronary angiography Page 3/8

4 Postoperative Major Adverse Cardiac Events (MACE) Postoperative chest pain suspected to be cardiac in origin 0=no 1=yes 9=unknown First date of postoperative chest pain dd-mm-yyyy (leave blank if no) Postoperative troponin assay performed 0=no 1=yes 9=unknown Type of troponin assay 1=troponin I 2=troponin T Peak postoperative troponin value (leave blank if not available) (indicate units used). microgrammes/litre nanogrammes/litre If yes, date of peak postoperative troponin value dd-mm-yyyy (If peak provided please indicate date of peak postoperative troponin value) Upper reference limit of local troponin assay (99 th percentile) (indicate units used). microgrammes/litre nanogrammes/litre New postoperative ST-depression or elevation greater than 1mm on the ECG 0 =no 1=yes 9=unknown If yes, date of first new segment change on ECG dd-mm-yyyy D D M M Y Y Y Y New postoperative Q-waves on ECG 0=no 1=yes 9=unknown If yes, date of first new Q-waves on ECG dd-mm-yyyy New postoperative conduction defect on ECG 0=no 1=yes 9=unknown If yes, date of first new conduction defect on ECG dd-mm-yyyy If yes, nature of new conduction defect on ECG 1=RBBB; 2=LBBB; 3=bifasicular block; 4=trifasicular block; 5=first degree block; 6=second degree block (Mobitz type 1); 7=second degree block (Mobitz type 2); 8=complete heart block; 9=not applicable New wall motion abnormality on cardiac imaging 0=no 1=yes 2=no relevant imaging If yes, date new wall motion abnormality on cardiac imaging first detected Postoperative cardiac arrest 0=no 1=yes Date of postoperative cardiac arrest D D M M D Y Y Y Page 4/8

5 Post-mortem evidence of coronary thrombosis 0=no; 1=yes (not within stent); (Leave blank if not applicable/available) 2=yes including in-stent thrombosis; 9=unknown Discharged from hospital alive 0=no 1=yes Date of discharge from hospital dd-mm-yyyy Date of death in the case of in-hospital death dd-mm-yyyy Cause of death in the case of hospital death 1=cardiovascular; 2=cerebrovascular; 3=bleeding; 4=infection; 5=multi-system organ failure; 6=other non cardiovascular Drop out Did the subject discontinue participation? 0=no 1=yes If yes, date of last contact dd-mm-yyyy If yes, reason for drop out? Page 5/8

6 III Medications 1. Aspirin 0=no 1=taking prior to admission for surgery 2=started on admission for surgery 9=unknown Aspirin preoperative daily dose if applicable Aspirin discontinued prior to surgery 0=no 1=yes 9=not discontinued Date aspirin discontinued before surgery dd-mm-yyyy (Leave blank if no/or not discontinued) Aspirin (re)started after surgery 0=no 1=yes Date aspirin (re)started after surgery Aspirin postoperative daily dose 2. Clopidogrel 0=no 1=taking prior to admission for surgery 2=started on admission for surgery 9=unknown Clopidogrel preoperative daily dose if applicable Clopidogrel discontinued prior to surgery 0=no 1=yes Date Clopidogrel discontinued before surgery Clopidogrel (re)started after surgery 0=no 1=yes 9=not discontinued Date clopidogrel (re)started after surgery dd-mm-yyyy (Leave blank if no/or not discontinued) Clopidogrel postoperative daily dose (put 0 Leave blank if not applicable) 3. Other anti-platelet agents 1=no; 2=Taking prior to admission for surgery; 3=Started on admission for surgery 9=unknown Name of other anti-platelet agent 1=prasugrel; 2=tricagrelor; 3=other If other, please enter name here: Other anti-platelet agent preoperative daily dose if applicable Other anti-platelet agent (re)started after surgery 0=no 1=yes Page 6/8

7 Date other anti-platelet agent (re)started after surgery Other anti-platelet agent postoperative daily dose 4. Beta-blocker 0=no; 1=chronic, continued in perioperative period; 2=Chronic, discontinued during periopative period; 3=acute perioperative only; 9=unknown Please choose beta-blocker(s) used in preoperative and/or intraoperative period: Bisoprolol 0=no 1=yes. Atenolol 0=no 1=yes Metoprolol 0=no 1=yes Betaxolol 0=no 1=yes Carvedilol 0=no 1=yes. Labetolol 0=no 1=yes Nadolol 0=no 1=yes Pindolol 0=no 1=yes Sotolol 0=no 1=yes Timolol 0=no 1=yes Page 7/8

8 Was an additional or other beta-blocker used before, during or after surgery? 0=no 1=yes If yes, specify which: 1=bisoprolol; 2=atenolol; 3=metoprolol; 4=betaxolol; 5=carvedilol; 6=labetolol; 7=nadolol; 8=pindolol; 9=sotolol; 10=timolol If yes, when was the additional beta-blocker used? Pre-operatively 0=no 1=yes During surgery 0=no 1=yes After surgery 0=no 1=yes 5. Statin 0=no; 1=chronic continued in perioperative period; 2=chronic, discontinued during periopative period; 3=acute perioperative only; 9=unknown Name of the statin used in intraoperative period: Atorvastatin 0=no 1=yes Fluvastatin 0=no 1=yes Lovastatin 0=no 1=yes Pravastatin 0=no 1=yes Rosuvastatin 0=no 1=yes Simvastatin 0=no 1=yes Page 8/8