Exercise Stress CMR Comparison Study

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Exercise MRI and Exercise Nuclear Scintigraphy in Patients With Suspected Coronary Artery Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504269
• Other study ID #: 2007H0132
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: March 28, 2016
• Start date: August 2007

Study information

• Verified date: March 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being done to compare standard nuclear exercise stress testing to exercise stress magnetic resonance imaging (MRI). The investigators have successfully shown that exercise MRI works well in healthy volunteers, and the next step is to test if it works as well as nuclear stress testing in patients with known or suspected heart disease.

MRIs offers superior image quality compared to echocardiography and nuclear imaging, and have the ability to image both function and perfusion. Combining the superior image quality of Cardiac MRI with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Ross Heart Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer Dickerson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of coronary artery disease	Cardiac MRI with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease.	baseline	No