Arteriosclerosis, Near-infrared Spectroscopy, Peri-procedural Myocardial Infarction, Coronary Artery Disease
Conditions
Brief 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.
Interventions
PROCEDURECombined 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
PROCEDUREConventional PCI
Conventional PCI
Sponsors
North Texas Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the incidence and size of periprocedural MI, as assessed by the peak post-PCI troponin distribution | 18-24 hours post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the incidence of >3x and >10x upper limit of normal increase in CK-MB | 18-24 hours post-procedure |
| Reduction in the incidence of slow flow/no-reflow post PCI | 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 | 30 days |
Outcome results
None listed