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Comparative Effectiveness of Stress Tests (EXACT-COST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Jennifer Dickerson, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01875315
First received: June 5, 2013
Last updated: October 14, 2014
Last verified: October 2014

June 5, 2013
October 14, 2014
September 2012
August 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01875315 on ClinicalTrials.gov Archive Site
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Comparative Effectiveness of Stress Tests
EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests

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.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
Other: Diagnostic Cardiac Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
August 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Debbie Scandling, B.S. 614-688-5623 debbie.scandling@osumc.edu
United States
 
NCT01875315
2011H0295
Yes
Jennifer Dickerson, The Ohio State University
Jennifer Dickerson
Not Provided
Principal Investigator: Jennifer Dickerson, MD Ohio State University
Ohio State University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP