Cardiovascular DiseasesPhase 3NCT00000503
Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries
A Phase 3 study testing nitroglycerin, streptokinase and heart catheterization in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the effect of non-surgical reperfusion on infarct size in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- nitroglycerin, streptokinase and heart catheterization
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1982to Oct 1987
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
To assess the effect of non-surgical reperfusion on infarct size in patients with acute myocardial infarction.
Read the 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.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Being tested
- nitroglycerin, streptokinase, heart catheterization
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitroglycerinDrug
streptokinaseDrug
heart catheterizationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startAug 1982
- Study completionOct 1987
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Peter Rentrop, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000503
- Sponsor's protocol ID
- 22
- Other IDs
- R01HL028843-05
- Status last verified
- Jan 2000
- First submitted
- 27 Oct 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
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. doi: 10.1016/0735-1097(89)90054-5.
PubMed 2500472Zhan S, Wang J, Zhu M, Liu Y, Han F, Sun L, Wang Q, Huang Z. The Inhibitory Effects of NCT503 and Exogenous Serine on High-Selenium Induced Insulin Resistance in Mice. Nutrients. 2025 Jan 16;17(2):311. doi: 10.3390/nu17020311.
PubMed 39861441
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Non-Surgical Reperfusion of the Coronary Arteries
- ClinicalTrials.gov ID
- NCT00000503
- Acronym / sponsor ID
- 22
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1982
- Study completion
- Oct 1987 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitroglycerin | Drug | – |
| streptokinase | Drug | – |
| heart catheterization | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Background: PubMed 2500472Rentrop 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. doi: 10.1016/0735-1097(89)90054-5.
- Derived from this study: PubMed 39861441Zhan S, Wang J, Zhu M, Liu Y, Han F, Sun L, Wang Q, Huang Z. The Inhibitory Effects of NCT503 and Exogenous Serine on High-Selenium Induced Insulin Resistance in Mice. Nutrients. 2025 Jan 16;17(2):311. doi: 10.3390/nu17020311.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rentrop
MOUNT SINAI HOSPITAL
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nitroglycerin, streptokinase and heart catheterization in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.