Angina After PCI: a Systems Medicine Study

NCT06854302 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-03-03

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854302 on ClinicalTrials.gov