Accelerated Stress CMR in Coronary Artery Disease

NCT05221762 | Active Not Recruiting

• 2 other identifiers: 0726258996
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the diagnostic performance of an accelerated stress CMR protocol, comparing it with that of standard CMR assessment.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Diagnostic performance of accelerated CMR (qualitative assessment)

  Per vessel diagnostic accuracy of the accelerated CMR protocol (with qualitative perfusion assessment) and standard CMR protocol versus invasive coronary angiography with fractional flow reserve.

  6 weeks

• Diagnostic performance of accelerated CMR (quantitative assessment)

  Per vessel diagnostic accuracy of the accelerated CMR protocol (with quantitative perfusion assessment) and standard CMR protocol versus invasive coronary angiography with fractional flow reserve.

  6 weeks

Secondary Outcomes (14)

• Sensitivity of accelerated CMR (vessel level)

  6 weeks

• Specificity of accelerated CMR (vessel level)

  6 weeks

• Sensitivity of accelerated CMR (patient level)

  6 weeks

• Specificity of accelerated CMR (patient level)

  6 weeks

• Diagnostic performance of accelerated CMR versus CTCA/FFRCT (1)

  6 weeks

Interventions

Cardiovascular magnetic resonance (CMR) DIAGNOSTIC_TEST

Cardiovascular magnetic resonance (CMR) at 3 Tesla

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected angina referred to Glenfield Hospital, Leicester, UK, for invasive coronary angiography.

You may qualify if:

• Patients aged ≥18 years
• Referred for invasive coronary angiography for investigation of chest pain
• Willing and able to give informed consent
• Willing and able (in the Investigators opinion) to comply with all study requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
• Able to understand written English

You may not qualify if:

• Recent acute coronary syndrome (\< 6 months)
• Severe claustrophobia
• Absolute contraindications to CMR - those with MR conditional or safe devices will be included
• Second-/third-degree atrioventricular block
• Severe chronic obstructive pulmonary disease
• Moderate-severe asthma
• Estimated glomerular filtration rate \<30 ml/min/1.73m2
• Women who are pregnant, breast-feeding or of child-bearing potential (premenopausal women)
• Contraindication to iodinated contrast
• Participants who have participated in a research study involving an investigational product in the past 12 weeks
• Patients unable to understand written English

Sponsors & Collaborators

• University of Leicester: lead
• University of Glasgow: collaborator
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, Leics, LE3 9QP, United Kingdom

Location

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

• Jayanth Arnold

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: February 3, 2022
• Study Start: July 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

GB (1)