Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05152888 · ClinicalTrials.gov registry record · Phase 4
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
A Phase 4 study of Stable Coronary Disease, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05152888 is a Phase 4 study of Stable Coronary Disease that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05152888, a Phase 4 study of Stable Coronary Disease, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Evolocumab
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-03-03 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05152888
The ClinicalTrials.gov registry entry for NCT05152888 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stable Coronary Disease appearing as the primary indexed condition, and to 1 intervention - of which Evolocumab is the first listed.
NCT05152888 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05152888 about?
NCT05152888 is a clinical study titled "The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk". 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 fr...
What is the current status of trial NCT05152888?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2022-03-03. Estimated completion is 2027-12-31.
What conditions does trial NCT05152888 study?
This clinical trial studies the following conditions: Stable Coronary Disease.
What interventions are being tested in trial NCT05152888?
The interventions under investigation include: Evolocumab (DRUG).
Who is sponsoring clinical trial NCT05152888?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05152888 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.