Identifying thresholds for symptom relief in stable angina

Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

This study is testing if certain blood flow measurements can help relieve chest pain in patients with stable angina who are considering a heart procedure.

Quick facts

• Study type: Observational
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Imperial College London (Academic / other)
• Locations: 6 sites (Basildon and 5 other locations)
• Trial ID: NCT05459051 on ClinicalTrials.gov

What this trial studies

This observational study aims to determine the invasive haemodynamic thresholds associated with symptom relief in patients with stable angina. It involves a randomized, double-blinded, placebo-controlled approach to assess the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) in 58 patients. Participants will undergo both rest and exercise physiological assessments to evaluate their angina symptoms under controlled conditions. The study focuses on patients eligible for percutaneous coronary intervention (PCI) due to significant coronary stenosis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults eligible for PCI with significant single-vessel coronary stenosis and evidence of ischaemia.

Not a fit: Patients with multivessel disease, significant left main stem disease, or those who have had recent acute coronary syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from stable angina by identifying specific thresholds for symptom relief.

How similar studies have performed: Previous studies have explored similar physiological assessments in angina, but this specific approach to identifying invasive thresholds is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
* 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:

* Age \<18 years
* 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

Where this trial is running

Basildon and 5 other locations

• Mid and South Essex NHS Foundation Trust — Basildon, United Kingdom (Recruiting)
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust — Bournemouth, United Kingdom (Recruiting)
• Imperial College NHS Trust — London, United Kingdom (Recruiting)
• Royal Free Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
• St George's University Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
• Portsmouth Hospitals NHS Trust — Portsmouth, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Rasha Al-Lamee, PhD MRCP — Imperial College London
• Study coordinator: Fiyyaz Ahmed-Jushuf, MBBS MRCP

Conditions Stable Angina; Symptoms; Angina; Physiology; Placebo