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ENROLLING BY INVITATION
NCT06854302

Angina After PCI: a Systems Medicine Study

Sponsor: NHS National Waiting Times Centre Board

View on ClinicalTrials.gov

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.

Official title: Angina After PCI: a Systems Medicine Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-09-17

Completion Date

2028-10-01

Last Updated

2025-03-03

Healthy Volunteers

No

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.

Locations (4)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Golden Jubilee National Hospital

Clydebank, Dunbartonshire, United Kingdom

University Hospital Hairmyres

East Kilbride, Lanarkshire, United Kingdom

Leeds General Infirmary

Leeds, Yorkshire, United Kingdom