- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612521
Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing percutaneous coronary balloon angioplasty and stenting
- Ages 18 years and older
- TIMI III flow on the initial angiography
- Native coronary artery lesions
Exclusion Criteria:
- Patients unable to give consent
- Adenosine allergy
- Severe asthma with bronchial reactivity
- Cardiogenic or circulatory shock
- Acute or chronic total coronary artery occlusions
- Patients requiring Rotablator therapy
- In stent restenosis
- Second or third degree AV block without a permanent pacemaker
- ST-Elevation MI
- Elevated baseline CK/ CK-MB or troponin levels (Pre-existing Non-STemi)
- Current pregnancy
- Patients not already on statin therapy or intolerant of statins
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.
|
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.
|
Other: 2
Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peri-procedural myocardial infarction
Time Frame: 24 hours post procedure
|
24 hours post procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TIMI frame count
Time Frame: Final angiographic picture during the index procedure
|
Final angiographic picture during the index procedure
|
Death, myocardial infarction or target lesion revascularization
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marino Labinaz, MD FRCP, Director of Interventional Cardiology - University of Ottawa Heart Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Coronary Stenosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
Other Study ID Numbers
- 2007446-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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