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New treatment option for Angina (Stable)
Official title Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
ClinicalTrials.gov ID: NCT07386418
What this study is testing
- What it's testing
- ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
- 2 severe epicardial stenoses in a major coronary artery, defined as:
- ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)
- Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA
- Evidence of ischaemia on an invasive or non-invasive test, including:
You likely can't join if
- Age \<18 years
- Acute coronary syndrome within 3 months
- Previous coronary artery bypass graft
- Significant left main stem disease
- Single lesion amenable to PCI
- Chronic total occlusion of the target artery
See the full eligibility criteria
- Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
- 2 severe epicardial stenoses in a major coronary artery, defined as:
- ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)
- Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA
- Evidence of ischaemia on an invasive or non-invasive test, including:
- Physiological test during invasive coronary angiography (ICA)
- Dobutamine stress echocardiography (DSE)
- Stress perfusion cardiac magnetic resonance (CMR)
- Myocardial perfusion scintigraphy (MPS)
- Fractional flow reserve computed-tomography (FFR-CT)
- Age \<18 years
- Acute coronary syndrome within 3 months
- Previous coronary artery bypass graft
- Significant left main stem disease
- Single lesion amenable to PCI
- Chronic total occlusion of the target artery
- Moderate to severe valve disease
- LVEF ≤40%, contraindication to PCI or drug-eluting stents
- PCI performed with drug-eluting balloons without stenting
- Contraindication to antiplatelet therapy
- Contraindication to adenosine
- Physical inability to exercise with an ergometer
- Femoral artery access
- Pregnancy
- Inability to consent
The study team makes the final eligibility decision.
Where it's taking place
- Basildon, United Kingdom
- Bournemouth, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basildon, United Kingdom; Bournemouth, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.