Comparative Effectiveness of Stress Tests (EXACT-COST)
Verified April 2015 by Ohio State University
Information provided by (Responsible Party):
Jennifer Dickerson, The Ohio State University
First received: June 5, 2013
Last updated: April 20, 2015
Last verified: April 2015
The primary objective of this project is to demonstrate that a new approach to cardiac stress imaging that combines treadmill exercise with cardiac magnetic resonance (CMR) provides valuable clinical information in a cost-effective manner.
Coronary Artery Disease
Other: Diagnostic Cardiac Imaging
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests
Primary Outcome Measures:
- Total patient direct and indirect medical costs for one year following stress testing will be less for patients undergoing stress CMR as compared to patients undergoing stress Nuclear. [ Time Frame: baseline ] [ Designated as safety issue: No ]
Patients will undergo either Stress CMR or stress Nuclear testing. For each individual patient, the cost of the initial test, the subsequent follow-up costs, and the total costs over the follow-up period will be calculated. Total costs will be collected for direct medical, direct non-medical and indirect costs. Direct medical costs will include those applied for medications, imaging, invasive therapies and healthcare services; as well as costs resulting from side effects or complications from each of the testing strategies. Direct non-medical costs will include those incurred due to CAD-related illness or the need to seek care, such as caregiver costs and patient transportation costs. Indirect costs, will be defined as lost productivity due to time lost from work, early death or disability.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- any patient referred for stress SPECT
- known or suspected ischemic heart disease
- ability to perform adequate treadmill stress
- 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)
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: NCT01875315
|Brigham And Womens Hospital
|Boston, Massachusetts, United States, 02115 |
|The Lindner Center at the Christ Hospital
|Cinncinatti, Ohio, United States, 45219 |
|The Ohio State University
|Columbus, Ohio, United States, 43210 |
|University of Pittsburgh Medical Center
|Pittsburgh, Pennsylvania, United States, 15213 |
||Jennifer Dickerson, MD
||Ohio State University
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.
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.
||Jennifer Dickerson, Assistant Professor-Clinical, The Ohio State University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 5, 2013
||April 20, 2015
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 23, 2015
Coronary Artery Disease
Arterial Occlusive Diseases