Trials / Terminated
TerminatedNCT02601664
Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- North Texas Veterans Healthcare System · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Arteriosclerosis
- Near-infrared Spectroscopy
- Peri-procedural Myocardial Infarction
- Coronary Artery Disease
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| PROCEDURE | Conventional PCI | Conventional PCI |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-01-01
- Completion
- 2016-02-01
- First posted
- 2015-11-10
- Last updated
- 2016-06-29
Source: ClinicalTrials.gov record NCT02601664. Inclusion in this directory is not an endorsement.