Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing

NCT ID: NCT01592565

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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This study is being done to demonstrate a powerful new method for detecting heart disease that combines the proven prognostic capability of exercise stress testing with the superior image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to exercise stress SPECT for detecting obstructive artery disease.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Diagnostic Cardiac Imaging

Cardiac Magnetic Resonance (CMR) offers superior image quality compared to echocardiography and nuclear imaging, and the ability to image both function and perfusion. Combining the superior image quality of CMR with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease. This project is expected to show that CMR is at least equivalent to nuclear stress imaging and could potentially replace it in many instances, eliminating the need for radioisotope administration and the associated exposure of patients to ionizing radiation.

Intervention Type OTHER

Eligibility Criteria

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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 (computed tomography angiography) in patients not referred for cath after 2 weeks)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Karolina Zareba

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Dickerson, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Lindner Center at The Christ Hospital

Cinncinatti, Ohio, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20624294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19038687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22190228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18272005 (View on PubMed)

Other Identifiers

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2007H0132 JD

Identifier Type: -

Identifier Source: org_study_id

NCT01504269

Identifier Type: -

Identifier Source: nct_alias

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