Oxygen-enhanced Magnetic Resonance Imaging (OE-MRI) of the Heart: A Feasibility Study

NCT05163327 | Withdrawn

• 1 other identifier: Cardiac-OE-MRI-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory pilot study aims to set up cardiac oxygen enhanced magnetic resonance imaging (OE-MRI). It will involve 10 healthy volunteers and 10 patients with known coronary artery disease (CAD) having a MRI scan. If positive, this data would be used to power an appropriately sized study assessing the utility of cardiac OE-MRI in CAD and other cardiac pathologies.

Conditions

Coronary Artery Disease

Keywords

MRI, Imaging

Outcome Measures

Primary Outcomes (1)

• To apply OE-MRI in the heart and compare it to BOLD imaging

  To apply OE-MRI in the heart and compare it to BOLD imaging

  24 Months

Study Arms (2)

Healthy Volunteer

10 Volunteers (Male or Female), aged18 or over, with no known history of Coronary Artery Disease

Procedure: Oxygen-enhanced Cardiac MRI

Known Coronary Artery Disease

10 Volunteers (Male orFemale), aged 18 or over,with a known significant (defined as =\> 70% stenosis) single or 2 vessel Coronary Artery Disease

Procedure: Oxygen-enhanced Cardiac MRI

Interventions

Oxygen-enhanced Cardiac MRI PROCEDURE

The MRI scan will include assessment of cardiac function. Myocardial magnetic properties (T1, T2, T2\*) will be measured while patients are breathing room air, oxygen and during an infusion of adenosine. The scan will last for approximately 60 minutes. Prior to the scan patients will have an intravenous cannula (venflon) placed in an arm vein.

Healthy Volunteer; Known Coronary Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten healthy volunteers and 10 patients with CAD

You may qualify if:

• healthy volunteers and 10 patients with known significant (defined as \> 70% stenosis) single or 2 vessel CAD
• Male or female \> 18 years of age
• Females will be non-pregnant and non-lactating

You may not qualify if:

• Contraindication to MRI (including claustrophobia)
• History of any significant lung disease including asthma and COPD
• History of type II respiratory failure
• Second degree and higher atrio-ventricular conduction delay
• Patients taking Dipyridamole, or theophylline-based medication
• Significant left main stem coronary artery disease
• Recent myocardial infarction (within 2 months)
• Unstable angina
• Abnormal heart rhythm e.g. atrial fibrillation, atrial flutter, atrial or ventricular bigeminy
• Pregnancy/breast-feeding. Women of childbearing potential (not \>2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (13)

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Chris Miller, MBChB, MRCP

  Manchester University NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)