Predicting Plaque Growth Using Blood Flow Stress Markers: A Proof-of-Concept Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorQueen Mary University of London

About this trial

Coronary artery disease occurs when fatty deposits (plaques) build up inside the arteries that supply blood to the heart. Some plaques remain stable, while others continue to grow or become more likely to rupture, which can lead to a heart attack. Identifying plaques that are at higher risk of progression could help doctors provide earlier and more personalized treatment.

The purpose of this study is to determine whether combining information about blood flow within the coronary arteries with information about a person's biological response to blood flow can improve prediction of plaque growth. Participants undergoing treatment for coronary artery disease will have a specialized heart scan to assess blood flow patterns around plaques in their coronary arteries. Researchers will also collect blood samples to study cells that line blood vessels and investigate how these cells respond to blood flow forces.

The study will follow participants over time to determine whether plaques are more likely to progress in individuals who show a stronger biological response to abnormal blood flow. The findings may help researchers develop new ways to identify patients at higher risk of future heart problems and support the development of more personalized approaches to prevention and treatment of coronary artery disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥40

Stable angina, defined as typical symptoms with evidence of reversible ischemia in non-invasive test and/or documented obstructive coronary artery disease on coronary angiography (>70% stenosis of at least one major epicardial coronary artery or positive fractional flow reserve study)

Patient that is willing and can provide written informed consent.

Disqualifiers

Acute coronary syndrome within <3 months

Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m²

Previous coronary artery bypass surgery

Decompensated heart failure, or left ventricular ejection fraction ≤30%

Trial design

Design model

Single group

Treatments tested in this trial

  • PCCTA scan

    Procedure/Surgery

    During the scans, the patient will be cardiac monitored using ECG synchronisation. PCCTA scan acquisition and parameters will follow Barts Health's standard operating procedures and institutional protocols.

  • Endothelial cell isolation from peripheral blood sample

    Other intervention

    A 50mL blood sample will be collected from consenting patients. The blood will be processed to isolate peripheral mononuclear cells. These cells will be cultured to support the growth of endothelial colony forming cells (ECFCs).

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: Single armOther 2 interventions

Trial outcomes

Primary outcomes

1

Percentage change in plaque burden over 12 months

Percentage change in plaque burden over 12 months, analysed using linear regression with response to WSS as a continuous predictor

Time frame
From the first CT scan to the second CT scan- 12 months apart
2

ECFC isolation from peripheral blood sample

Peripheral blood will be drawn at the point of recruitment. Blood will be processed to culture endothelial colony forming cells (ECFCs).

Time frame
The process takes around 4 weeks after blood draw

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Mary University of London

Lead sponsor

Barts & The London NHS Trust

Collaborator