Comparative Effectiveness of Stress Tests (EXACT-COST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 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: March 5, 2014
Last verified: March 2014
  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: Open Label
Primary Purpose: Diagnostic
Official Title: EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests

Resource links provided by NLM:


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 ] [ 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.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, 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
Jennifer Dickerson
Investigators
Principal Investigator: Jennifer Dickerson, MD Ohio State University
  More Information

Publications:
MR-compatible treadmill for exercise stress cardiac magnetic resonance imaging Foster EL, Arnold JW, Jekic M, Bender JA, Balasubramanian V, Thavendiranathan P, Dickerson JA, Raman SV, Simonetti OP. Magn Reson Med. 2011 Aug 16. doi: 10.1002/mrm.23059.
Real-time cine and myocardial perfusion with treadmill exercise stress cardiovascular magnetic resonance in patients referred for stress SPECT Raman SV, Dickerson JA, Jekic M, Foster EL, Pennell ML, McCarthy B and Simonetti OP, J Cardiovasc Magn Reson. 2010; 12(1): 41.

Responsible Party: Jennifer Dickerson, Assistant Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01875315     History of Changes
Other Study ID Numbers: 2011H0295
Study First Received: June 5, 2013
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

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 July 20, 2014