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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham And Womens Hospital, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diagnostic Cardiac Imaging

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests

Acronym: EXACT-COST

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Jun 11, 2013
Registry last updated: Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed