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

This study is currently recruiting participants.

Verified November 2012 by Ohio State University

Sponsor:

Information provided by (Responsible Party):

Jennifer Dickerson, The Ohio State University

ClinicalTrials.gov Identifier:

NCT01592565

First received: March 29, 2012

Last updated: November 8, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention
Coronary Artery Disease	Other: Diagnostic Cardiac Imaging

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	An In-state Multi-center Evaluation of Treadmill Exercise Stress Cardiac Magnetic Resonance

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness MRI Scans

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	227
Study Start Date:	August 2010
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 in patients not referred for cath after 2 weeks)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592565

Contacts

Contact: Debbie Scandling, B.S.

614-688-5623

debbie.scandling@osumc.edu

Locations

United States, Ohio
The Lindner Center at The Christ Hospital	Recruiting
Cinncinatti, Ohio, United States, 45219
CWRU/ UH Hospitals	Not yet recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University Of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Jennifer Dickerson

Investigators

Principal Investigator:

Jennifer Dickerson, MD

Ohio State University

More Information

Publications:

Real-time cine and myocardial perfusion with treadmill exercise stress cardiovascular magnetic resonance in patients referred for stress SPECT Raman SV, Dickerson JA, Jekic M, Foster EL, Pennell ML, McCarthy B and Simonetti OP, J Cardiovasc Magn Reson. 2010; 12(1): 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.

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.

Responsible Party:	Jennifer Dickerson, Assistant Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier:	NCT01592565 History of Changes
Other Study ID Numbers:	2007H0132 JD
Study First Received:	March 29, 2012
Last Updated:	November 8, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

To Top