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Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing (EXACT)
This study has been completed.
Sponsor:
Ohio State University
Information provided by (Responsible Party):
Karolina Zareba, Ohio State University
ClinicalTrials.gov Identifier:
NCT01592565
First received: March 29, 2012
Last updated: January 26, 2017
Last verified: January 2017
| Tracking Information | ||||
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| First Received Date ICMJE | March 29, 2012 | |||
| Last Updated Date | January 26, 2017 | |||
| Start Date ICMJE | August 2010 | |||
| Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Exercise stress CMR has equivalent or superior diagnostic and prognostic value compared to exercise stress nuclear scintigraphy in patients suspected of CAD (coronary artery disease) [ Time Frame: baseline ] Exercise nuclear and CMR examinations including aggregate assessment of exercise parameters, ECG findings, myocardial perfusion, segmental left ventricular wall motion (CMR only), and viability will be independently reviewed offline by a consensus of two reviewers blinded to the results of the other imaging study, and each test will be classified as either negative/adequate stress, negative/inadequate stress, positive for ischemia, or fixed abnormality/no ischemia. |
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| Original Primary Outcome Measures ICMJE |
Exercise stress CMR has equivalent or superior diagnostic and prognostic value compared to exercise stress nuclear scintigraphy in patients suspected of CAD [ Time Frame: baseline ] Exercise nuclear and CMR examinations including aggregate assessment of exercise parameters, ECG findings, myocardial perfusion, segmental left ventricular wall motion (CMR only), and viability will be independently reviewed offline by a consensus of two reviewers blinded to the results of the other imaging study, and each test will be classified as either negative/adequate stress, negative/inadequate stress, positive for ischemia, or fixed abnormality/no ischemia. |
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| Change History | Complete list of historical versions of study NCT01592565 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing | |||
| Official Title ICMJE | An In-state Multi-center Evaluation of Treadmill Exercise Stress Cardiac Magnetic Resonance | |||
| Brief Summary | 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 | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE | Coronary Artery Disease | |||
| Intervention ICMJE | Other: 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. |
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| Study Arms | Not Provided | |||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 227 | |||
| Completion Date | Not Provided | |||
| Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01592565 | |||
| Other Study ID Numbers ICMJE | 2007H0132 JD | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Karolina Zareba, Ohio State University | |||
| Study Sponsor ICMJE | Ohio State University | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Ohio State University | |||
| Verification Date | January 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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