Dobutamine vs Adenosine CMR Study

NCT03661827 | Completed DMC

• 1 other identifier: 0683
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Coronary Artery Disease; Cardiac MRI

Outcome Measures

Primary Outcomes (1)

• Presence of severe CAD (stenosis >70%) on invasive angiography and will be assessed on a per vessel basis

  if positive

  2 years

Secondary Outcomes (3)

• Haemodynamic/splenic T1 mapping value in (ms) to adenosine by cardiac MRI scan.

  2 years

• Myocardial perfusion reserve (ml/min/g) by cardiac MRI scan.

  2 years

• Presence of inducible wall motion abnormality as a response to dobutamine by Cardiac MRI

  2 years

Study Arms (1)

Patients with heart failure

EXPERIMENTAL

Patients with heart failure

Diagnostic Test: Stress Cardiac MRI

Interventions

Stress Cardiac MRI DIAGNOSTIC_TEST

Dobutamine and adenosine stress MRI

Patients with heart failure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \. 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.

You may not qualify if:

• 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.
• \. 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University of Leicester

Leicester, United Kingdom

Location

Related Publications (11)

• Greenwood JP, Maredia N, Younger JF, Brown JM, Nixon J, Everett CC, Bijsterveld P, Ridgway JP, Radjenovic A, Dickinson CJ, Ball SG, Plein S. Cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary heart disease (CE-MARC): a prospective trial. Lancet. 2012 Feb 4;379(9814):453-60. doi: 10.1016/S0140-6736(11)61335-4. Epub 2011 Dec 22.

  PMID: 22196944 BACKGROUND

• Hamirani YS, Kramer CM. Cardiac MRI assessment of myocardial perfusion. Future Cardiol. 2014 May;10(3):349-58. doi: 10.2217/fca.14.18.

  PMID: 24976472 BACKGROUND

• Klem I, Heitner JF, Shah DJ, Sketch MH Jr, Behar V, Weinsaft J, Cawley P, Parker M, Elliott M, Judd RM, Kim RJ. Improved detection of coronary artery disease by stress perfusion cardiovascular magnetic resonance with the use of delayed enhancement infarction imaging. J Am Coll Cardiol. 2006 Apr 18;47(8):1630-8. doi: 10.1016/j.jacc.2005.10.074. Epub 2006 Mar 27.

  PMID: 16631001 BACKGROUND

• Morton G, Chiribiri A, Ishida M, Hussain ST, Schuster A, Indermuehle A, Perera D, Knuuti J, Baker S, Hedstrom E, Schleyer P, O'Doherty M, Barrington S, Nagel E. Quantification of absolute myocardial perfusion in patients with coronary artery disease: comparison between cardiovascular magnetic resonance and positron emission tomography. J Am Coll Cardiol. 2012 Oct 16;60(16):1546-55. doi: 10.1016/j.jacc.2012.05.052. Epub 2012 Sep 19.

  PMID: 22999722 BACKGROUND

• Karamitsos TD, Arnold JR, Pegg TJ, Cheng AS, van Gaal WJ, Francis JM, Banning AP, Neubauer S, Selvanayagam JB. Tolerance and safety of adenosine stress perfusion cardiovascular magnetic resonance imaging in patients with severe coronary artery disease. Int J Cardiovasc Imaging. 2009 Mar;25(3):277-83. doi: 10.1007/s10554-008-9392-3. Epub 2008 Nov 27.

  PMID: 19037746 BACKGROUND

• Bruder O, Wagner A, Lombardi M, Schwitter J, van Rossum A, Pilz G, Nothnagel D, Steen H, Petersen S, Nagel E, Prasad S, Schumm J, Greulich S, Cagnolo A, Monney P, Deluigi CC, Dill T, Frank H, Sabin G, Schneider S, Mahrholdt H. European Cardiovascular Magnetic Resonance (EuroCMR) registry--multi national results from 57 centers in 15 countries. J Cardiovasc Magn Reson. 2013 Jan 18;15(1):9. doi: 10.1186/1532-429X-15-9.

  PMID: 23331632 BACKGROUND

• Khoo JP, Grundy BJ, Steadman CD, Sonnex EP, Coulden RA, McCann GP. Stress cardiovascular MR in routine clinical practice: referral patterns, accuracy, tolerance, safety and incidental findings. Br J Radiol. 2012 Oct;85(1018):e851-7. doi: 10.1259/bjr/14829242. Epub 2012 Mar 28.

  PMID: 22457320 BACKGROUND

• Wilson RF, Wyche K, Christensen BV, Zimmer S, Laxson DD. Effects of adenosine on human coronary arterial circulation. Circulation. 1990 Nov;82(5):1595-606. doi: 10.1161/01.cir.82.5.1595.

  PMID: 2225364 BACKGROUND

• Gerber BL, Raman SV, Nayak K, Epstein FH, Ferreira P, Axel L, Kraitchman DL. Myocardial first-pass perfusion cardiovascular magnetic resonance: history, theory, and current state of the art. J Cardiovasc Magn Reson. 2008 Apr 28;10(1):18. doi: 10.1186/1532-429X-10-18.

  PMID: 18442372 BACKGROUND

• Kramer CM, Barkhausen J, Flamm SD, Kim RJ, Nagel E; Society for Cardiovascular Magnetic Resonance Board of Trustees Task Force on Standardized Protocols. Standardized cardiovascular magnetic resonance (CMR) protocols 2013 update. J Cardiovasc Magn Reson. 2013 Oct 8;15(1):91. doi: 10.1186/1532-429X-15-91.

  PMID: 24103764 BACKGROUND

• Schwitter J, Wacker CM, van Rossum AC, Lombardi M, Al-Saadi N, Ahlstrom H, Dill T, Larsson HB, Flamm SD, Marquardt M, Johansson L. MR-IMPACT: comparison of perfusion-cardiac magnetic resonance with single-photon emission computed tomography for the detection of coronary artery disease in a multicentre, multivendor, randomized trial. Eur Heart J. 2008 Feb;29(4):480-9. doi: 10.1093/eurheartj/ehm617. Epub 2008 Jan 21.

  PMID: 18208849 RESULT

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jayanth Arnold, Dr

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: yES
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 7, 2018
• Study Start: February 5, 2019
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)