Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries
Information source: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
Intervention: nitroglycerin (Drug); streptokinase (Drug); heart catheterization (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Peter Rentrop, Affiliation: Mount Sinai Hospital, New York
Summary
To assess the effect of non-surgical reperfusion on infarct size in patients with acute
myocardial infarction.
Clinical Details
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Detailed 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.
The study completion date listed in this record was obtained from the Query/View/Report
(QVR) System.
Eligibility
Minimum age: 18 Years.
Maximum age: 77 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Related publications: Rentrop KP, Feit F, Sherman W, Stecy P, Hosat S, Cohen M, Rey M, Ambrose J, Nachamie M, Schwartz W, et al. Late thrombolytic therapy preserves left ventricular function in patients with collateralized total coronary occlusion: primary end point findings of the Second Mount Sinai-New York University Reperfusion Trial. J Am Coll Cardiol. 1989 Jul;14(1):58-64.
Starting date: August 1982
Last updated: November 25, 2013
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