RECRUITING

The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Impact of Pcsk-9 Inhibition on PET Coronary Flow Reserve in Patients at High Cardiovascular Risk (EMPOWER Study)

Quick Facts

Study Start:2022-03-03

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05152888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age: ≥ 50 (men) or ≥ 55 (women) * Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL * Stable coronary artery disease (without plan to undergo revascularization before randomization) defined as one or more of the following: 1. Abnormal nuclear perfusion imaging 1. At least moderate ischemia involving \>10% of the LV myocardium or 2. Global coronary flow reserve (CFR) \<1.8 or 3. Stress myocardial blood flow (MBF) \<1.8 2. Abnormal coronary angiography (invasive coronary angiography or coronary computed tomography) 1. ≥ 50% stenosis in ≥ 2 coronary vessels or 2. Diffuse atherosclerosis in a 3-vessel distribution 3. Elevated coronary calcium score 1. CAC \>100 + \>1 ASCVD risk factor 2. CAC \>300 * If the patient is on a statin they must be on a stable dose for at least 3 months prior to enrollment.	* History of myocardial infarction or stroke * CABG \< 3 months prior to screening * Homozygous familial hypercholesterolemia * History of cardiac transplantation * LV ejection fraction \< 40% or New York Heart Failure Association (NYHA) class III-IV for angina and/or dyspnea. * History of infiltrative or hypertrophic cardiomyopathy * Severe valvular disease * Uncontrolled or recurrent ventricular tachycardia * Fasting triglycerides \> 500 mg/dL * GFR ˂ 30 mL/min/1.73 m² * Current use of a PCSK-9 inhibitor * Currently pregnant or breastfeeding * Contraindication to receive vasodilator agent * Latex allergy

Inclusion Criteria

Exclusion Criteria

* Age: ≥ 50 (men) or ≥ 55 (women)
* Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL
* Stable coronary artery disease (without plan to undergo revascularization before randomization) defined as one or more of the following:
1. Abnormal nuclear perfusion imaging
1. At least moderate ischemia involving \>10% of the LV myocardium or
2. Global coronary flow reserve (CFR) \<1.8 or
3. Stress myocardial blood flow (MBF) \<1.8
2. Abnormal coronary angiography (invasive coronary angiography or coronary computed tomography)
1. ≥ 50% stenosis in ≥ 2 coronary vessels or
2. Diffuse atherosclerosis in a 3-vessel distribution
3. Elevated coronary calcium score
1. CAC \>100 + \>1 ASCVD risk factor
2. CAC \>300
* If the patient is on a statin they must be on a stable dose for at least 3 months prior to enrollment.

* History of myocardial infarction or stroke
* CABG \< 3 months prior to screening
* Homozygous familial hypercholesterolemia
* History of cardiac transplantation
* LV ejection fraction \< 40% or New York Heart Failure Association (NYHA) class III-IV for angina and/or dyspnea.
* History of infiltrative or hypertrophic cardiomyopathy
* Severe valvular disease
* Uncontrolled or recurrent ventricular tachycardia
* Fasting triglycerides \> 500 mg/dL
* GFR ˂ 30 mL/min/1.73 m²
* Current use of a PCSK-9 inhibitor
* Currently pregnant or breastfeeding
* Contraindication to receive vasodilator agent
* Latex allergy

Contacts and Locations

Study Contact

Diana Lopez, MD

CONTACT

617-525-8268

dlopez@bwh.harvard.edu

Leanne Barrett

CONTACT

617-732-4719

lbarrett11@bwh.harvard.edu

Principal Investigator

Diana Lopez, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Diana Lopez, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-03

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-03-03

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Stable Coronary Disease