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Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis

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ClinicalTrials.gov Identifier: NCT00612521
Recruitment Status : Terminated (At half the sample size, the results were negative with no benefit demonstrated with adenosine.)
First Posted : February 11, 2008
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date August 29, 2012
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
Peri-procedural myocardial infarction [ Time Frame: 24 hours post procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
  • TIMI frame count [ Time Frame: Final angiographic picture during the index procedure ]
  • Death, myocardial infarction or target lesion revascularization [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
Official Title  ICMJE Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
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. 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronary Artery Stenosis
  • Coronary Artery Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 1
    Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.
    Intervention: Drug: Adenosine
  • 2
    Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.
    Intervention: Drug: Adenosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2012)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2008)
400
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00612521
Other Study ID Numbers  ICMJE 2007446-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marino Labinaz, MD FRCP Director of Interventional Cardiology - University of Ottawa Heart Institute
PRS Account Ottawa Heart Institute Research Corporation
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP