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

This study has been terminated.
(At half the sample size, the results were negative with no benefit demonstrated with adenosine.)
Sponsor:
Information provided by (Responsible Party):
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00612521
First received: January 25, 2008
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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
Coronary Artery Stenosis
Coronary Artery Disease
Drug: Adenosine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Peri-procedural myocardial infarction [ Time Frame: 24 hours post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TIMI frame count [ Time Frame: Final angiographic picture during the index procedure ] [ Designated as safety issue: No ]
  • Death, myocardial infarction or target lesion revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612521

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Principal Investigator: Marino Labinaz, MD FRCP Director of Interventional Cardiology - University of Ottawa Heart Institute
  More Information

No publications provided

Responsible Party: University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00612521     History of Changes
Other Study ID Numbers: 2007446-01H
Study First Received: January 25, 2008
Last Updated: August 28, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
Coronary artery disease
Coronary artery stenting
peri-procedural myonecrosis
Adenosine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 16, 2014