Comparative Effectiveness of Stress Tests

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01875315
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (4)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Brigham And Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

The Lindner Center at the Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States