Actively Recruiting
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
Led by Brigham and Women's Hospital · Updated on 2025-11-04
50
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study protocol is a single-arm, open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease. Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic and/or from the BWH Nuclear Cardiology Laboratory. A target sample size of 50 participants will undergo imaging with N-13 ammonia or Rubidium-82 positron emission tomography (PET) and coronary computed tomography angiography (CCTA) before and after 12 months of PCSK-9 inhibition with Evolocumab to assess changes in myocardial blood flow, and plaque volume. To help account for physiological changes that may occur in myocardial blood flow and inflammatory biomarkers during the study period, we will also recruit a parallel control group of stable CAD patients who will undergo similar baseline and 12-month imaging and biomarker assessment. We plan to recruit 15 patients in the parallel control group.
CONDITIONS
Official Title
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older for men, or 55 years or older for women
- Low-density lipoprotein cholesterol (LDL-C) of 70 mg/dL or higher
- Stable coronary artery disease without planned revascularization before randomization, defined by one or more of the following: abnormal nuclear perfusion imaging showing moderate ischemia involving more than 10% of the left ventricular myocardium, global coronary flow reserve less than 1.8, stress myocardial blood flow less than 1.8; abnormal coronary angiography with 50% or greater stenosis in two or more coronary vessels or diffuse atherosclerosis in a three-vessel distribution; elevated coronary calcium score with CAC over 100 plus more than one ASCVD risk factor, or CAC over 300
- If on a statin, stable dose for at least 3 months prior to enrollment
You will not qualify if you...
- History of myocardial infarction or stroke
- Coronary artery bypass graft (CABG) surgery less than 3 months before screening
- Homozygous familial hypercholesterolemia
- History of cardiac transplantation
- Left ventricular ejection fraction less than 40% or New York Heart Failure Association class III-IV with angina and/or dyspnea
- History of infiltrative or hypertrophic cardiomyopathy
- Severe valvular heart disease
- Uncontrolled or recurrent ventricular tachycardia
- Fasting triglycerides greater than 500 mg/dL
- Glomerular filtration rate 30 mL/min/1.73 m² or lower
- Current use of a PCSK-9 inhibitor
- Current pregnancy or breastfeeding
- Contraindication to receive vasodilator agents
- Latex allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
D
Diana Lopez, MD
CONTACT
L
Leanne Barrett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here