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

NCT00612521 | Terminated Phase 3

• 1 other identifier: 2007446-01H
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Stenosis; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Peri-procedural myocardial infarction

  24 hours post procedure

Secondary Outcomes (2)

• TIMI frame count

  Final angiographic picture during the index procedure

• Death, myocardial infarction or target lesion revascularization

  30 days

Study Arms (2)

1

OTHER

Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.

Drug: Adenosine

2

OTHER

Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.

Drug: Adenosine

Interventions

Adenosine DRUG

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing percutaneous coronary balloon angioplasty and stenting
• Ages 18 years and older
• TIMI III flow on the initial angiography
• Native coronary artery lesions

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Marino Labinaz, MD FRCP

  Director of Interventional Cardiology - University of Ottawa Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 11, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 29, 2012

Record last verified: 2012-08

Locations

CA (1)