Working… Menu

Dobutamine vs Adenosine CMR Study (DISCORDANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03661827
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 29, 2020
Information provided by (Responsible Party):
University of Leicester

Brief Summary:
This is a single centre, prospective diagnostic accuracy study to assess the comparative sensitivity of dobutamine versus adenosine for detection of severe non-infarct epicardial coronary artery stenosis in subjects with reduced LV EF ( EFed referred for clinical coronary angiography for investigation of symptoms or to establish the cause heart failure. Study participants will be identified from hospital angiography referral waiting lists, or already known with CAD and from heart failure outpatient clinics at Glenfield General Hospital. Clinical and CMR data will be collated on-site (at Glenfield General Hospital) from medical records stored and stress cardiac MRI scans at Glenfield General Hospital. The analysis will occur over a 12-month period following study commencement.

Condition or disease Intervention/treatment Phase
Heart Failure Coronary Artery Disease Cardiac MRI Diagnostic Test: Stress Cardiac MRI Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: yES
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy in Left Ventricular Systolic Dysfunction for Identifying Coronary Artery Disease With Dobutamine Versus Adenosine Non-invasive Stress Cardiac Magnetic Resonance Evaluation
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Patients with heart failure
Patients with heart failure
Diagnostic Test: Stress Cardiac MRI
Dobutamine and adenosine stress MRI

Primary Outcome Measures :
  1. Presence of severe CAD (stenosis >70%) on invasive angiography and will be assessed on a per vessel basis [ Time Frame: 2 years ]
    if positive

Secondary Outcome Measures :
  1. Haemodynamic/splenic T1 mapping value in (ms) to adenosine by cardiac MRI scan. [ Time Frame: 2 years ]
    if positive

  2. Myocardial perfusion reserve (ml/min/g) by cardiac MRI scan. [ Time Frame: 2 years ]
    if positive

  3. Presence of inducible wall motion abnormality as a response to dobutamine by Cardiac MRI [ Time Frame: 2 years ]
    if positive

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- HFrEF (LV EF≤40%, based on either echocardiography, CMR or nuclear perfusion imaging) consistent with recent guidelines for diagnosis of HFrEF [38] referred for investigation of CAD.

2. Age ≥18 years ≤90 years old 3. Understand written and verbal English. 4. Patients are not involved in other research studies within the last year.

Exclusion Criteria:

  • Absolute contraindication to MRI. 2. Absolute contraindication to dobutamine OR adenosine; 3. Stage III-V renal disease (estimated glomerular filtration rate <30ml/min/1.73m2.

    4. Previous coronary artery bypass grafting. 5. Unstable angina or MI within 6 weeks. 6. Persistent atrial fibrillation 7. Participants who are involved in current research or have recently been involved in any research prior to recruitment 8. Participants who don't speak or understand verbal or written English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03661827

Layout table for location contacts
Contact: Ahmed Abdelaty, MSc MRCP 07460687084

Layout table for location information
United Kingdom
University of Leicester Recruiting
Leicester, United Kingdom
Contact: Ahmed Abdelaty, MSc    07460687084   
Principal Investigator: Jayanth Arnold, Dphil         
Sponsors and Collaborators
University of Leicester
Layout table for investigator information
Principal Investigator: Jayanth Arnold, Dr University of Leicester
Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: University of Leicester Identifier: NCT03661827    
Other Study ID Numbers: 0683
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases