BridgeMD
New treatment option for Microvascular Coronary Dysfunction
Official title Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study
ClinicalTrials.gov ID: NCT06681896
What this study is testing
- What it's testing
- The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction. The main questions it aims to answer are: 1.
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
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
- Age ≥18
- Angina or angina equivalent symptoms
- Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing \<40% epicardial vessel stenosis or 40-90%...
- Evidence of microvascular dysfunction on ICA (CFR \<2.5 and/or AchFR \<1.5)
You likely can't join if
- New York Heart Association class III/IV heart failure
- Severe left ventricular impairment (ejection fraction≤35%)
- Severe heart valve disease
- Significant cardiomyopathy (as assessed by a cardiologist)
- Severe hypertension (defined as blood pressure \>180/120mmHg (despite three anti-hypertensive agents)
- Uncontrolled arrhythmia
See the full eligibility criteria
- Age ≥18
- Angina or angina equivalent symptoms
- Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing \<40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8
- Evidence of microvascular dysfunction on ICA (CFR \<2.5 and/or AchFR \<1.5)
- New York Heart Association class III/IV heart failure
- Severe left ventricular impairment (ejection fraction≤35%)
- Severe heart valve disease
- Significant cardiomyopathy (as assessed by a cardiologist)
- Severe hypertension (defined as blood pressure \>180/120mmHg (despite three anti-hypertensive agents)
- Uncontrolled arrhythmia
- A history of aortic dissection, recent (\<6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe...
- Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT)
- Physical inability to participate in exercise
- Significant claustrophobia or metallic implants which would limit MRI imaging
- Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease)
- Current participation in another intervention-based trial
- Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.
The study team makes the final eligibility decision.
Where it's taking place
- Bath, United Kingdom
- Bristol, 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 study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Bath, United Kingdom; Bristol, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.