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Trial record 50 of 1127 for:    adenosine

Dobutamine vs Adenosine CMR Study (DISCORDANCE)

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ClinicalTrials.gov Identifier: NCT03661827
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : April 18, 2019
Sponsor:
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 Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : January 1, 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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03661827


Contacts
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Contact: Ahmed Abdelaty, MSc MRCP 07460687084 abdelaty.ahmed@nhs.net

Locations
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United Kingdom
University of Leicester Recruiting
Leicester, United Kingdom
Contact: Ahmed Abdelaty, MSc    07460687084    abdelaty.ahmed@nhs.net   
Principal Investigator: Jayanth Arnold, Dphil         
Sponsors and Collaborators
University of Leicester
Investigators
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Principal Investigator: Jayanth Arnold, Dr University of Leicester

Publications of Results:
Other Publications:

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03661827     History of Changes
Other Study ID Numbers: 0683
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Adenosine
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dobutamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Protective Agents