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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North Texas Veterans Healthcare System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings