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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Dickerson, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01592565
First received: March 29, 2012
Last updated: March 5, 2014
Last verified: March 2014
  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:


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 Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  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
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, see Learn About Clinical Studies.

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

Locations
United States, Ohio
The Lindner Center at The Christ Hospital
Cinncinatti, Ohio, United States, 45219
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University Of Pittsburgh Medical Center
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.
MR-compatible treadmill for exercise stress cardiac magnetic resonance imaging Foster EL, Arnold JW, Jekic M, Bender JA, Balasubramanian V, Thavendiranathan P, Dickerson JA, Raman SV, Simonetti OP. Magn Reson Med. 2011 Aug 16. doi: 10.1002/mrm.23059.

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: March 5, 2014
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 September 18, 2014