Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Comparative Effectiveness of Stress Tests (EXACT-COST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Karolina Zareba, Ohio State University
ClinicalTrials.gov Identifier:
NCT01875315
First received: June 5, 2013
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Coronary Artery Disease
Other: Diagnostic Cardiac Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests

Further study details as provided by Ohio State University:

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 ]
    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: 200
Study Start Date: September 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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

Contacts
Contact: Debbie Scandling, B.S. 614-688-5623 debbie.scandling@osumc.edu

Locations
United States, Massachusetts
Brigham And Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Ohio
The Lindner Center at the Christ Hospital Recruiting
Cinncinatti, Ohio, United States, 45219
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jennifer Dickerson, MD Ohio State University
  More Information

Publications:
Responsible Party: Karolina Zareba, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT01875315     History of Changes
Other Study ID Numbers: 2011H0295
Study First Received: June 5, 2013
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 24, 2017