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

• ClinicalTrials.gov Identifier: NCT00612521
• Recruitment Status: Terminated
• First Posted: February 11, 2008
• Last Update Posted: August 29, 2012
• Sponsor: Ottawa Heart Institute Research Corporation
• Information provided by (Responsible Party): Ottawa Heart Institute Research Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Stenosis; Coronary Artery Disease	Drug: Adenosine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
• Study Start Date: August 2007
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Peri-procedural myocardial infarction [ Time Frame: 24 hours post procedure ]

Secondary Outcome Measures :

1. TIMI frame count [ Time Frame: Final angiographic picture during the index procedure ]
2. Death, myocardial infarction or target lesion revascularization [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Ontario

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation

Investigators

• Principal Investigator: Marino Labinaz, MD FRCP; Director of Interventional Cardiology - University of Ottawa Heart Institute

More Information

• Responsible Party: Ottawa Heart Institute Research Corporation
• ClinicalTrials.gov Identifier: NCT00612521 History of Changes
• Other Study ID Numbers: 2007446-01H
• First Posted: February 11, 2008
• Last Update Posted: August 29, 2012
• Last Verified: August 2012

Keywords provided by Ottawa Heart Institute Research Corporation:

Coronary artery disease; Coronary artery stenting; peri-procedural myonecrosis; Adenosine

Additional relevant MeSH terms:

Adenosine; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Vasodilator Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action