Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions (CONCERTO)

June 27, 2016 updated by: Emmanouil Brilakis, North Texas Veterans Healthcare System

Design: Single center, single-blind randomized controlled trial of patients with high risk native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will be randomized to either a combined intervention or conventional PCI. Cardiac biomarker measurements will be performed before PCI and 18-24 hours later.

Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible.

Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution in the two study groups.

The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3) Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Willing and able to provide informed consent and able to comply with study procedures and follow-up.
  3. Undergoing a clinically indicated left heart coronary catheterization
  4. Need PCI of a high-risk native coronary artery lesion. High-risk lesions will be defined as lesions with ≥2 contiguous yellow blocks on block chemogram.

Exclusion Criteria:

  1. Coexisting conditions that limit life expectancy to less than 30-days or that could affect the patient's compliance with the protocol.
  2. Positive pregnancy test or breast-feeding.
  3. High risk for bleeding.
  4. Subject is currently, or within the 30 preceding days, participating in a device or pharmaceutical treatment protocol.
  5. Clinical presentation with ST-segment elevation MI.
  6. Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
  7. Need for revascularization of multiple lesions during the index PCI.
  8. Unprotected left main (>50%) or equivalent left main disease.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combined Intervention
Combined intervention: pre-PCI intracoronary vasodilator and glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and complete coverage of the lipid core plaque, if technically feasible
Procedure: Combined Intervention
pre-PCI intracoronary vasodilator administration and glycoprotein IIb/IIIa inhibitor administration, use of an embolization protection device if technically feasible, and complete coverage of the lipid core plaque, if technically feasible
Active Comparator: Conventional PCI
Procedure: Conventional PCI
Conventional PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution
Time Frame: 18-24 hours post-procedure
18-24 hours post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB
Time Frame: 18-24 hours post-procedure
18-24 hours post-procedure
Reduction in the incidence of slow flow/no-reflow post PCI
Time Frame: 2-3 hours after
2-3 hours after
Lower incidence of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during 30-day follow-up
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

North Texas Veterans Healthcare System

Investigators

  • Study Chair: Emmanouil S Brilakis, MD, PhD, North Texas Veterans Healthcare System

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, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-083

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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