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Trial NCT00000503

Resource URI: http://static.linkedct.org/resource/trials/NCT00000503
linkedct:brief_title Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8483>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women, under 78 years of age. Suspected of having an acute myocardial infarction and who could be randomized within 12 hours of onset of qualifying pain.
linkedct:description BACKGROUND: Angiographic studies in the acute stage of myocardial infarction have shown complete occlusion in 75-85 percent and subtotal lesions in the remaining cases. Evidence for spasm in acutely occluded arteries has been reported. However, the majority of pathological as well as intraoperative examinations have yielded thrombotic material at the site of complete obstruction. Indirect evidence of thrombotic material was provided by successful intracoronary thrombolysis in 80 percent of infarct patients with complete obstruction. There could be causative relationships between spasm, intimal damage and coronary thrombosis. Selective applications of spasmolytic and/or thrombolytic substances into occluded vessels enabled high local concentrations with doses that caused little or no systemic effect. Angiographic verification of the results of this pharmacotherapy would help to clarify the role of spasm and thrombus in the pathogenesis of the acute coronary occlusion. Reperfusion in man has been achieved by coronary by-pass surgery in the acute stage of infarction. Follow-up angiography revealed significant improvement of left ventricular function. Intracoronary streptokinase infusion resulted in recanalization of acute coronary occlusion in 80 percent of cases within 20-30 minutes of infusion time. Reperfusion achieved by intervention angiography has been associated with improved local wall motion as well as improved left ventricular function. Improvement in left ventricular function depended on the duration of symptoms prior to reperfusion and on the presence or absence of collateral blood flow. Available data suggested that improvement was more likely to occur if reperfusion was achieved within 3-4 hours. However, since the majority of patients reached the hospital after greater than 4 hours of chest pain, study of functional changes following late reperfusion was of great practical significance. DESIGN NARRATIVE: The study was a randomized trial of myocardial reperfusion in acute myocardial infarction by selective intracoronary infusion of nitroglycerin and/or intracoronary infusion of streptokinase. The trial was single-blinded as to the interventional therapy; it was double-blinded as to the drug infused. The primary endpoint was the ejection fraction on the 10th day of intervention. Patients were assigned to one of four treatment arms: an intracoronary infusion of streptokinase; an intracoronary infusion of nitroglycerin; combined infusions of nitroglycerin and streptokinase; a control group receiving conventional therapy without acute catheterization. All patients underwent anticoagulant therapy with intravenous heparin followed by warfarin for three months. Patients were followed for a minimum of two years.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 77 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000503
rdfs:label Trial NCT00000503
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000503
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 22
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/46931>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000503>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/39243>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 1982
linkedct:study_design Treatment, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct:summary To assess the effect of non-surgical reperfusion on infarct size in patients with acute myocardial infarction.
rdf:type linkedct:trials
linkedct:verification_date January 2000