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Comparative Effectiveness of Stress Tests (EXACT-COST)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Cardiac Imaging
Sponsored by
Ohio State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brigham And Womens Hospital
  • The Lindner Center at the Christ Hospital
  • The Ohio State University
  • University of Pittsburgh Medical Center

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2013
Last Updated
August 26, 2019
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT01875315
Brief Title
Comparative Effectiveness of Stress Tests
Acronym
EXACT-COST
Official Title
EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Diagnostic Cardiac Imaging
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Dickerson, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham And Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
The Lindner Center at the Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19038687
Citation
Raman SV, Richards DR, Jekic M, Dickerson JA, Kander NH, Foster EL, Simonetti OP. Treadmill stress cardiac magnetic resonance imaging: first in vivo demonstration of exercise-induced apical ballooning. J Am Coll Cardiol. 2008 Dec 2;52(23):1884. doi: 10.1016/j.jacc.2008.08.046. No abstract available.
Results Reference
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PubMed Identifier
18272005
Citation
Jekic M, Foster EL, Ballinger MR, Raman SV, Simonetti OP. Cardiac function and myocardial perfusion immediately following maximal treadmill exercise inside the MRI room. J Cardiovasc Magn Reson. 2008 Jan 15;10(1):3. doi: 10.1186/1532-429X-10-3.
Results Reference
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PubMed Identifier
22190228
Citation
Foster EL, Arnold JW, Jekic M, Bender JA, Balasubramanian V, Thavendiranathan P, Dickerson JA, Raman SV, Simonetti OP. MR-compatible treadmill for exercise stress cardiac magnetic resonance imaging. Magn Reson Med. 2012 Mar;67(3):880-9. doi: 10.1002/mrm.23059. Epub 2011 Aug 16.
Results Reference
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PubMed Identifier
20624294
Citation
Raman SV, Dickerson JA, Jekic M, Foster EL, Pennell ML, McCarthy B, Simonetti OP. Real-time cine and myocardial perfusion with treadmill exercise stress cardiovascular magnetic resonance in patients referred for stress SPECT. J Cardiovasc Magn Reson. 2010 Jul 12;12(1):41. doi: 10.1186/1532-429X-12-41.
Results Reference
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Comparative Effectiveness of Stress Tests

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