Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty (PREVENT-ICARUS)

November 7, 2011 updated by: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Giuseppe De Luca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective coronary angioplasty

Exclusion Criteria:

Marked Bradycardia (< 40 bpm)

  • Previous allergy to adenosine
  • Inability to sign the informed consent
  • Asthma
  • Elevated cardiac enzymes (troponin I o CK-MB)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Intracoronary Placebo administration
Drug: Placebo
Intracoronary Placebo administration
ACTIVE_COMPARATOR: Adenosine
Intracoronary adenosine administration
Drug: Adenosine
Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in troponin I (> 3 times the upper normal limit)
Time Frame: At 12 hours after the procedure
At 12 hours after the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Giuseppe De Luca, MD, Aou Maggiore Della Carita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 93/09
  • 2009-013681-92 (REGISTRY: EUDRACT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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