Angina After PCI: a Systems Medicine Study
NCT06854302 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2025-03-03
Summary
Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Sometimes a drug-eluting-balloon is used instead of a stent.
This balloon coats the inside of the blood vessel to prevent re-narrowing. Research is needed to clarify the causes of ongoing angina and its impact on patients and the NHS, and to identify which patients will or will not benefit from a stent (hence avoiding over-treatment in the future).
We plan a 5-year UK-wide multicenter study involving up to 600 patients with angina undergoing coronary angioplasty (with or without a stent). They will initially have a heart MRI scan. We will assess what might influence the recurrence of angina in the year after the angioplasty procedure. We will measure small blood vessel function in the heart and the amount of plaque persisting after PCI.
Patients who report angina after coronary angioplasty usually have a second invasive angiogram. Instead, we will invite patients to have a heart MRI scan allowing us to also assess whether this scan might be more useful than a repeat angiogram in guiding clinical care. We will collaborate with life scientists, mathematicians, statisticians, and health economists to better understand causes and health economic implications of angina arising after coronary angioplasty procedures.
Conditions
- Angina (Stable)
- Ischemic Heart Disease (IHD)
Interventions
- DIAGNOSTIC_TEST
-
Cardiovascular magnetic resonance imaging
Observational diagnostic tests will include adenosine-stress perfusion cardiovascular magnetic resonance imaging before undergoing percutaneous coronary intervention.
- DIAGNOSTIC_TEST
-
Coronary physiology
Invasive coronary function tests using a diagnostic guidewire (PressureWire-X, Abbott), thermodilution, intravenous or intracoronary infusion of adenosine and intracoronary infusions of acetylcholine.
Sponsors & Collaborators
-
Robertson Centre for Biostatistics - University of Glasgow
collaborator UNKNOWN -
British Heart Foundation
collaborator OTHER -
Abbott Medical Devices
collaborator INDUSTRY -
CoreAalst BV
collaborator INDUSTRY -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
NHS National Waiting Times Centre Board
lead OTHER
Principal Investigators
-
Colin Berry, BSc MBChB PhD · University of Glasgow
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-17
- Primary Completion
- 2027-09-30
- Completion
- 2028-10-01
Countries
- United Kingdom
Study Locations
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