ISRCTN44258879
Completed
Not Applicable
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
- Not Applicable
- 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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