Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000503
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effect of non-surgical reperfusion on infarct size in patients with acute myocardial infarction
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 andor 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 andor 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 QueryViewReport QVR System
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 andor 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 andor 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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL028843-05 | NIH | None | httpsreporternihgovquickSearchR01HL028843-05 |