Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI Study)

Completed

• Conditions: Acute myocardial infarction (AMI); Circulatory System

• Registration Number: ISRCTN44258879
• Lead Sponsor: niversity of Ottawa Heart Institute (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Ischemic chest discomfort of =30 minutes duration
2. Aged 18 years and older, either sex
3. Onset of Chest Pain =6 hours prior to entry into the study and one of the following high risk criteria:
3.1. Anterior AMI with ST-segment elevation =2 mm in each of at least contiguous precordial leads (V1-V6)
3.2. Extensive nonanterior AMI on a standard 12 lead electrocardiogram (ECG) defined as:
3.2.1. Eight or more leads with =0.1 mV ST elevation or depression, or both; ST segment elevation of >1 mm (0.1 mV) must be present in two or more contiguous electrocardiographic leads
3.2.2. Sum of ST-segment elevation >20 mm measured 60 msec after the J-point
4. Killip 3 and either ST segment elevation of >1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old
5. Systolic blood pressure <100 mmHg and either ST segment elevation of >1 mm (0.1mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

Exclusion Criteria

1. Low risk AMI defined as having the absence of high risk features defined above
2. Acute bleeding
3. History of stroke or central nervous system (CNS) damage
4. Major surgery or trauma within the past 3 months
5. Uncontrolled hypertension (SBP =200 mmHg and/or DBP =120 mmHg despite treatment)
6. Prolonged (>10 min) cardiopulmonary resuscitation
7. Inadequate vascular access 8. Previous coronary artery bypass graft (CABG)
9. PTCA within the last 6 months
10. Abciximab (ReoPro TM) or other GP IIb/IIIa antagonists within the preceding 7 days
11. Coagulation disorder (i.e. international normalized ratio (INR) >2.0, platelets <100,000/mm^3, or hematocrit <30%
12. Current warfarin treatment
13. Within 6 hours randomization, either:
a. Standard unfractionated heparin (heparin sodium) =5000 IU
b. A subcutaneous therapeutic dose of any low molecular weight heparin
14. Intolerance to aspirin
15. Other medical condition that is likely to result in death within 12 months
16. Participation in a study with another investigational device or drug <4 weeks
17. Pregnancy
18. Known severe renal impairment (creatinine >300 µmol/l
19. Sustained hypotension defined as SBP <90 mmHg or the need for intravenous (IV) inotropes and/or intraaortic balloon counter pulsation to support the blood pressure
20. Known severe contrast (dye) allergy
21. Inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified