Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing (EXACT)

Tracking Information
First Submitted Date ICMJE	March 29, 2012
First Posted Date ICMJE	May 7, 2012
Last Update Posted Date	January 27, 2017
Study Start Date ICMJE	August 2010
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 26, 2017)	Exercise stress CMR has equivalent or superior diagnostic and prognostic value compared to exercise stress nuclear scintigraphy in patients suspected of CAD (coronary artery disease) [ Time Frame: baseline ]; Exercise nuclear and CMR examinations including aggregate assessment of exercise parameters, ECG findings, myocardial perfusion, segmental left ventricular wall motion (CMR only), and viability will be independently reviewed offline by a consensus of two reviewers blinded to the results of the other imaging study, and each test will be classified as either negative/adequate stress, negative/inadequate stress, positive for ischemia, or fixed abnormality/no ischemia.
Original Primary Outcome Measures ICMJE; (submitted: May 3, 2012)	Exercise stress CMR has equivalent or superior diagnostic and prognostic value compared to exercise stress nuclear scintigraphy in patients suspected of CAD [ Time Frame: baseline ]; Exercise nuclear and CMR examinations including aggregate assessment of exercise parameters, ECG findings, myocardial perfusion, segmental left ventricular wall motion (CMR only), and viability will be independently reviewed offline by a consensus of two reviewers blinded to the results of the other imaging study, and each test will be classified as either negative/adequate stress, negative/inadequate stress, positive for ischemia, or fixed abnormality/no ischemia.
Change History	Complete list of historical versions of study NCT01592565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing
Official Title ICMJE	An In-state Multi-center Evaluation of Treadmill Exercise Stress Cardiac Magnetic Resonance
Brief Summary	This study is being done to demonstrate a powerful new method for detecting heart disease that combines the proven prognostic capability of exercise stress testing with the superior image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to exercise stress SPECT for detecting obstructive artery disease.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Coronary Artery Disease
Intervention ICMJE	Other: Diagnostic Cardiac Imaging; Cardiac Magnetic Resonance (CMR) offers superior image quality compared to echocardiography and nuclear imaging, and the ability to image both function and perfusion. Combining the superior image quality of CMR with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease. This project is expected to show that CMR is at least equivalent to nuclear stress imaging and could potentially replace it in many instances, eliminating the need for radioisotope administration and the associated exposure of patients to ionizing radiation.
Study Arms	Not Provided
Publications *	Raman SV, Dickerson JA, Jekic M, Foster EL, Pennell ML, McCarthy B, Simonetti OP. Real-time cine and myocardial perfusion with treadmill exercise stress cardiovascular magnetic resonance in patients referred for stress SPECT. J Cardiovasc Magn Reson. 2010 Jul 12;12:41. doi: 10.1186/1532-429X-12-41.; Raman SV, Richards DR, Jekic M, Dickerson JA, Kander NH, Foster EL, Simonetti OP. Treadmill stress cardiac magnetic resonance imaging: first in vivo demonstration of exercise-induced apical ballooning. J Am Coll Cardiol. 2008 Dec 2;52(23):1884. doi: 10.1016/j.jacc.2008.08.046.; Foster EL, Arnold JW, Jekic M, Bender JA, Balasubramanian V, Thavendiranathan P, Dickerson JA, Raman SV, Simonetti OP. MR-compatible treadmill for exercise stress cardiac magnetic resonance imaging. Magn Reson Med. 2012 Mar;67(3):880-9. doi: 10.1002/mrm.23059. Epub 2011 Aug 16.; Jekic M, Foster EL, Ballinger MR, Raman SV, Simonetti OP. Cardiac function and myocardial perfusion immediately following maximal treadmill exercise inside the MRI room. J Cardiovasc Magn Reson. 2008 Jan 15;10:3. doi: 10.1186/1532-429X-10-3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 3, 2012)	227
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: any patient referred for stress SPECT; known or suspected ischemic heart disease; ability to perform adequate treadmill stress Exclusion Criteria: any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia); renal insufficiency (GFR < 40); known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA (computed tomography angiography) in patients not referred for cath after 2 weeks)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01592565
Other Study ID Numbers ICMJE	2007H0132 JD
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Karolina Zareba, Ohio State University
Study Sponsor ICMJE	Ohio State University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Jennifer Dickerson, MD Ohio State University
PRS Account	Ohio State University
Verification Date	January 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP