Actively Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Led by Imperial College London · Updated on 2026-02-18
60
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
S
St George's University Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how different coronary artery narrowings (stenoses) affect the threshold at which angina symptoms appear during exercise. This invasive study focuses on patients with stable angina who have two coronary stenoses suitable for treatment with percutaneous coronary intervention (PCI). The goal is to measure the angina threshold, defined as the level of blood flow reduction causing symptoms, using detailed physiological assessments during cardiac catheterization. The study involves inflating a balloon inside the coronary arteries during exercise on a supine ergometer to replicate the narrowing and measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) at each stenosis. After stenting the arteries, the order of testing each lesion is randomized. The balloon is inflated gradually until angina symptoms occur, then deflated and removed. This procedure is repeated for both stenoses to compare their angina thresholds. Participants will undergo invasive coronary angiography, pressure wire measurements, and exercise testing during the procedure. Additional imaging such as computed tomography coronary angiography, quantitative coronary angiography, intravascular imaging, and cardiac magnetic resonance imaging will be done within 14 days to correlate anatomical features with the angina threshold. Researchers will also assess symptoms, quality of life, and pain perception. The primary outcome is the difference in FFR and NHPR angina thresholds measured during the procedure. The study is expected to continue until December 2028.
CONDITIONS
Brief Title
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for PCI due to angina or angina-like symptoms during exercise
- Have two severe epicardial coronary artery narrowings in a major artery with diameter 2.5mm or larger
- Evidence of heart ischemia from invasive or non-invasive tests such as physiological tests during angiography, dobutamine stress echocardiography, stress perfusion cardiac MRI, myocardial perfusion scintigraphy, or fractional flow reserve CT
- Adults aged 18 years or older
You will not qualify if you...
- Age under 18 years
- Acute coronary syndrome within the last 3 months
- Previous coronary artery bypass graft surgery
- Significant disease in the left main coronary artery
- Only a single lesion suitable for PCI
- Chronic total blockage of the target artery
- Moderate to severe heart valve disease
- Left ventricular ejection fraction of 40% or less
- Contraindications to PCI, drug-eluting stents, antiplatelet therapy, or adenosine
- PCI performed with drug-eluting balloons without stenting
- Unable to exercise on a supine ergometer
- Access via femoral artery
- Pregnancy
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day procedure
Participants undergo PCI to treat stable angina by managing coronary artery narrowings.
1 in-person procedure visit
Duration - Same day as PCI
Following PCI, participants have invasive angina threshold measurements using a balloon inflation and pressure wire during exercise to assess physiological responses.
1 intra-procedural assessment
Duration - Up to 14 days after PCI
Participants undergo imaging and symptom assessments including CT coronary angiography, quantitative coronary angiography, cardiac MRI, and questionnaires to correlate with angina thresholds.
1 to 2 visits within 14 days
Trial Site Locations
Total: 6 locations
1
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
Not Yet Recruiting
2
University Hospitals Dorset NHS Foundation Trust
Bournemouth, United Kingdom
Not Yet Recruiting
3
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
4
Royal Free London NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
5
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
6
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
Not Yet Recruiting
Research Team
K
Kayla Chiew, MBBS MRCP
R
Rasha Al-Lamee, MBBS PhD MRCP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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