Recruiting

B-MORE

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT04126148

Conditions

Coronary Artery Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.

Conditions

Coronary Artery Stenosis

Study ID

NCT04126148

Start date

Jul 4, 2019

Status verified date

Oct, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Age matched Healthy participants (150)

Healthy Participants Age: > 40y No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system

Coronary Artery Disease (CAD) Patients (200)

Coronary Artery Disease (CAD) Patients Age > 18 y Patients with an Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.

Primary outcome measure

  • B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity [ Time Frame: 2019-2022 ]

Central Contacts and Locations

Central contacts

Elizabeth Konidis

514 934-1934elisavet.konidis@muhc.mcgill.ca

Adonis Rodaros

514 934-1934adonis.rodaros@muhc.mcgill.ca

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Matthias G Friedrich, MD

514 934-1934mgfriedrich@gmail.com

Elizabeth Konidis

514 934-1934elisavet.konidis@muhc.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Oct 24, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-10-24.