Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
NCT ID: NCT05459051
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
58 participants
OBSERVATIONAL
2022-09-01
2025-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with stable angina
* Symptomatic
* Anatomically severe single-vessel coronary artery disease
* Physiological evidence of myocardial ischaemia
Rest-angina physiological assessment
The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Exercise-angina physiological assessment
The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Interventions
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Rest-angina physiological assessment
The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Exercise-angina physiological assessment
The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Eligibility Criteria
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Inclusion Criteria
* Anatomical evidence of significant single-vessel coronary stenosis defined by either:
* ≥70% stenosis on invasive coronary angiography (ICA)
* Severe stenosis on CT coronary angiography (CTCA)
* Physiological evidence of ischaemia with a positive test on at least one of the following:
* Stress echocardiography
* Cardiac magnetic resonance perfusion
* Myocardial perfusion scintigraphy
* Invasive metrics of coronary physiology
Exclusion Criteria
* Recent acute coronary syndrome
* Previous coronary artery by-pass graft
* Significant left main stem disease
* Multivessel disease (defined as \>50% angiographic stenosis in other vessels)
* Chronic total occlusion in the target artery
* Moderate to severe valvular disease
* Moderate to severe left ventricular impairment
* Chronotropic incompetence with a pacemaker
* Contraindication to PCI or a drug-eluting stents
* Contraindication to antiplatelet therapy
* Contraindication to adenosine
* Moderate to severe respiratory disease
* Physical inability to exercise
* Pregnant
* Inability to consent
18 Years
ALL
No
Sponsors
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Royal Free Hospital NHS Foundation Trust
OTHER
Mid and South Essex NHS Foundation Trust
OTHER
St George's University Hospitals NHS Foundation Trust
OTHER
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
OTHER_GOV
Portsmouth Hospitals NHS Trust
OTHER_GOV
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Rasha Al-Lamee, PhD MRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Mid and South Essex NHS Foundation Trust
Basildon, , United Kingdom
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, , United Kingdom
Imperial College NHS Trust
London, , United Kingdom
Royal Free Hospital NHS Foundation Trust
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22HH7546
Identifier Type: OTHER
Identifier Source: secondary_id
P91528
Identifier Type: -
Identifier Source: org_study_id
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