Status:
TERMINATED
Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Coronary Artery Stenosis
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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....
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 load...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00612521
Start Date
August 1 2007
End Date
September 1 2008
Last Update
August 29 2012
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7