Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial.

Azienda Ospedaliero Universitaria Maggiore della Carita1 site in 1 country260 target enrollmentNovember 2009

ConditionsCoronary Angioplasty

InterventionsPlacebo Adenosine

DrugsAdenosine Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Coronary Angioplasty
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Enrollment: 260
Locations: 1
Primary Endpoint: Increase in troponin I (> 3 times the upper normal limit)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.

Detailed Description

This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo. This is a double-blind randomized trial single-center study. The enrollment will last 10 months.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

August 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Eligibility Criteria

Inclusion Criteria

•Patients undergoing elective coronary angioplasty

Exclusion Criteria

•Marked Bradycardia (\< 40 bpm)
•Previous allergy to adenosine
•Inability to sign the informed consent
•Elevated cardiac enzymes (troponin I o CK-MB)

Arms & Interventions

Placebo

Intracoronary Placebo administration

Intervention: Placebo

Adenosine

Intracoronary adenosine administration

Intervention: Adenosine

Outcomes

Primary Outcomes

Increase in troponin I (> 3 times the upper normal limit)

Time Frame: At 12 hours after the procedure

Secondary Outcomes

MACE(death, MI, urgent target-vessel revascularization)(72 hours)
Angiographic Coronary flow, as evaluated by corrected TIMI frame count.(1 minute after the final stent implantation)