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Sponsored by: |
University of Ottawa Heart Institute |
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Information provided by: | University of Ottawa Heart Institute |
ClinicalTrials.gov Identifier: | NCT00612521 |
Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days and long term. The cause of such damage is multi-factorial and includes distal propagation of atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation with inflammatory cells. Individually or together these events can occlude the micro-circulation and lead impaired blood flow to heart muscle.
The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is limited. More recently, there have been clinical studies looking at the administration of adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor distal flow post procedure and thus limit any myocardial damage. Although small numbers of subjects have been included in these trials, there have been encouraging preliminary data.
The aim of this study is to assess whether the use of intra-coronary adenosine given directly into the target coronary artery prior to stenting can reduce the incidence of myonecrosis (heart muscle damage)over placebo. We also aim to assess whether this translates to better outcomes at 30 day follow up.
Condition | Intervention | Phase |
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Coronary Artery Stenosis Coronary Artery Disease |
Drug: Adenosine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prophylactic Intra-Coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis |
Estimated Enrollment: | 400 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.
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Drug: Adenosine
For lesions in the left coronary system the patient will receive either 120 micrograms of adenosine in 20 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. For lesions in the right coronary system the patient will receive either 60 micrograms of adenosine in 10 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis.
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2
Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.
|
Drug: Adenosine
For lesions in the left coronary system the patient will receive either 120 micrograms of adenosine in 20 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. For lesions in the right coronary system the patient will receive either 60 micrograms of adenosine in 10 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis.
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Prior clinical studies looking at the administration of adenosine before coronary artery stenting have looked at small numbers of subjects and did not mandate previous statin therapy or high dose loading of clopidogrel before stenting, both of which can also help lower the rate of peri-procedural myonecrosis.
Our aim is to assess the above mentioned therapy in patients on optimal treatment with statins, dual antiplatelet agents and standard of care anti-coagulants.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marino Labinaz, MD FRCP | 16137615427 | mlabinaz@ottawaheart.ca |
Canada, Ontario | |
University of Ottawa Heart Institute | Recruiting |
Ottawa, Ontario, Canada, K1Y 4W7 | |
Contact: Marino Labinaz, MD FRCP 16137615427 mlabinaz@ottawaheart.ca | |
Principal Investigator: Marino Labinaz, MD FRCP |
Principal Investigator: | Marino Labinaz, MD FRCP | Director of Interventional Cardiology - University of Ottawa Heart Institute |
Responsible Party: | Department of Cardiology, University of Ottawa Heart Institute ( Prof. Marino Labinaz ) |
Study ID Numbers: | 2007446-01H |
Study First Received: | January 25, 2008 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00612521 |
Health Authority: | Canada: Health Canada |
Coronary artery disease Coronary artery stenting peri-procedural myonecrosis Adenosine |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Constriction, Pathologic |
Arteriosclerosis Ischemia Adenosine Coronary Stenosis Coronary Artery Disease |
Vasodilator Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |