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Comparative Effectiveness of Stress Tests (EXACT-COST)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875315
First Posted: June 11, 2013
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karolina Zareba, Ohio State University
June 5, 2013
June 11, 2013
September 21, 2017
September 2012
July 2018   (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 ]
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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.
 
Active, not recruiting
130
July 2018
July 2018   (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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01875315
2011H0295
Yes
Not Provided
Not Provided
Karolina Zareba, Ohio State University
Ohio State University
Not Provided
Principal Investigator: Jennifer Dickerson, MD Ohio State University
Ohio State University
September 2017

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