Angina After PCI: a Systems Medicine Study

NCT06854302 | Enrolling By Invitation

• 1 other identifier: 24/CARD/08
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief 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)

Keywords

Angina; Microvascular angina; Percutaneous coronary intervention; Systems medicine; Health economics; cohort study; coronary artery disease; Cardiovascular magnetic resonance imaging; Coronary physiology; Health-related quality of life; Clinical outcomes

Outcome Measures

Primary Outcomes (1)

• Residual angina after percutaneous coronary intervention.

  Residual angina post-PCI, defined as adjudicated, angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score \<90) occurring within one year of percutaneous coronary intervention.

  From enrolment to 12 months

Secondary Outcomes (14)

• Angina

  From enrolment to 12 months

• Myocardial perfusion reserve

  From enrolment to 12 months

• Fractional flow reserve post-percutaneous coronary intervention

  24 hours

• Coronary flow reserve after percutaneous coronary intervention

  24 hours

• Index of microvascular resistance after percutaneous coronary intervention

  24 hours

Other Outcomes (9)

• Inflammation

  From enrolment to 12 months

• Glycemic status

  From enrolment to 12 months

• Myocardial injury

  From enrolment to 12 months

Study Arms (1)

Patients receiving percutaneous coronary intervention

The study population will include individuals with stable angina who undergo stress perfusion cardiovascular magnetic resonance (CMR) imaging before invasive management. Eligibility will be sequentially assessed. Informed consent will initially be based on angina occurring in patients in whom there is a reasonable expectation for invasive management. Stress CMR imaging should be undertaken on either clinical grounds or for research. Potentially, 700 patients will provide written informed consent. Finally, eligibility will be reassessed during invasive management and eligibility will be confirmed when percutaneous coronary intervention is completed. The population will be defined by individuals who fulfil the eligibility criteria. The target sample size is 600 patients with complete data post-PCI. This sample size is anticipated to lead to approximately 200 participants who will report angina consistent with an Seattle Angina Questionnaire Angina Frequency score \<90.

Diagnostic Test: Cardiovascular magnetic resonance imaging; Diagnostic Test: Coronary physiology

Interventions

Cardiovascular magnetic resonance imaging DIAGNOSTIC_TEST

Observational diagnostic tests will include adenosine-stress perfusion cardiovascular magnetic resonance imaging before undergoing percutaneous coronary intervention.

Patients receiving percutaneous coronary intervention

Coronary physiology DIAGNOSTIC_TEST

Invasive coronary function tests using a diagnostic guidewire (PressureWire-X, Abbott), thermodilution, intravenous or intracoronary infusion of adenosine and intracoronary infusions of acetylcholine.

Patients receiving percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable angina in whom stress perfusion CMR imaging is reasonable on clinical and/or research grounds and in whom invasive management is plausible or intended will be eligible to participate.

You may qualify if:

• BEFORE INVASIVE MANGEMENT
• Angina by SAQ-7 Angina Frequency Score \<90\*
• Stress CMR imaging\*
• DURING INVASIVE MANAGEMENT
• PCI (successful)
• Coronary physiology assessment post-PCI.

You may not qualify if:

• Age \<=18 years
• Acute MI within 30 days
• Invasive management \>90 days after stress CMR
• Inability to comply with the protocol
• Lack of written informed consent.
• Pregnancy.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• Robertson Centre for Biostatistics - University of Glasgow: collaborator
• British Heart Foundation: collaborator
• Abbott Medical Devices: collaborator
• CoreAalst BV: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB20AY, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, Dunbartonshire, G814DY, United Kingdom

Location

University Hospital Hairmyres

East Kilbride, Lanarkshire, G75 8RG, United Kingdom

Location

Leeds General Infirmary

Leeds, Yorkshire, LS13EX, United Kingdom

Location

Related Publications (1)

• Crea F, Bairey Merz CN, Beltrame JF, Berry C, Camici PG, Kaski JC, Ong P, Pepine CJ, Sechtem U, Shimokawa H. Mechanisms and diagnostic evaluation of persistent or recurrent angina following percutaneous coronary revascularization. Eur Heart J. 2019 Aug 1;40(29):2455-2462. doi: 10.1093/eurheartj/ehy857.

  PMID: 30608528 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma, buffy coat, PAXgene

MeSH Terms

Conditions

Angina, Stable; Myocardial Ischemia; Angina Pectoris; Microvascular Angina; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Colin Berry, BSc MBChB PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology and Imaging

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: March 3, 2025
• Study Start: September 17, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the completion of the study
• Access Criteria: Bone fide research collaborators by contacting the chief investigator.

Locations

GB (4)