← Back to all trials
Active Not Recruiting
NCT04126148
Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
Conditions: Coronary Artery Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 236
Sponsor: Matthias Friedrich
Location: Rhode Island Hospital Providence Rhode Island
Summary
The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
Eligibility Criteria
Inclusion Criteria:
Healthy Participants
* Age: \> 40y
* No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system.
CAD Patients
* Age \> 18 y
* Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.
Exclusion Criteria:
ALL participants:
* General MRI contraindications: Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
* Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam.
* Regular nicotine consumption during the last 6 months.
Patients only
* Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam Contraindications to adenosine (2nd or 3rd A-V block, sinus node disease, asthma, bronchoconstrictive diseases).
* Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
* Previous myocardial infarction within 1 month
* Clinically unstable condition
* Significant or uncontrolled arrhythmia
Source: ClinicalTrials.gov (NCT04126148). StuddyBuddy aggregates publicly available trial information.