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

Phase 4TerminatedNCT02601664

North Texas Veterans Healthcare System3 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Arteriosclerosis Near-infrared Spectroscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB

Time frame: 18-24 hours post-procedure

Reduction in the incidence of slow flow/no-reflow post PCI

Time frame: 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