Trial record 4 of 16 for:    CONCERTO

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT02601664
First received: November 6, 2015
Last updated: December 1, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Arteriosclerosis
Near-infrared Spectroscopy
Peri-procedural Myocardial Infarction
Coronary Artery Disease
Procedure: Combined Intervention
Procedure: Conventional PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB [ Time Frame: 18-24 hours post-procedure ] [ Designated as safety issue: No ]
  • Reduction in the incidence of slow flow/no-reflow post PCI [ Time Frame: 2-3 hours after ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Conventional PCI
Procedure: Conventional PCI
Conventional PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02601664

Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Study Chair: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

Publications:

Responsible Party: Emmanouil Brilakis, Director of Cardiac Catheterization Laboratories, Professor of Medicine, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02601664     History of Changes
Other Study ID Numbers: 14-083 
Study First Received: November 6, 2015
Last Updated: December 1, 2015
Health Authority: United States: Institutional Board Review
United States: Federal Government
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Coronary Disease
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016