ISRCTN44258879
Completed
N/A
Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI Study)
niversity of Ottawa Heart Institute (Canada)0 sites170 target enrollmentSeptember 5, 2005
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Ottawa Heart Institute (Canada)
- Enrollment
- 170
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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%
Outcomes
Primary Outcomes
Not specified
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