Role of Stress Cardiac MRI in Predicting Adverse Clinical Events in Patients With Known or Suspected Ischemic Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01821924
Recruitment Status : Unknown
Verified March 2013 by Raymond Y. Kwong, MD, Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 1, 2013
Last Update Posted : April 1, 2013
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital

Brief Summary:
The investigators plan to use retrospective data to assess heart function and structure abnormalities through the use of an approved vasodilating agent for stress cardiac MRI tests. The investigators are interested in how these MRI findings relate to long-term prognosis in people who are at risk for cardiac disease.

Condition or disease
Coronary Artery Disease

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : January 2012
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. All-cause mortality, MI, heart failure hospitalization or documentation of an LV ejection fraction < 0.40 after index CMR at a follow-up. [ Time Frame: 5 years ]
    "Myocardial infarction" will be defined as hospital admission for acute coronary syndrome (defined by positive serum troponin level with documented electrocardiographic changes, clinical syndrome, or need for percutaneous or surgical revascularization). "Heart failure hospitalization" will be defined as any hospitalization for signs and symptoms of volume overload or dyspnea requiring diuretic therapy regardless of LV ejection fraction.

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients above the age of 21 who are clinically referred for stress cardiac MRI.

Inclusion Criteria:

  • Age >/= 21 years old
  • No contraindications for cardiac MRI (by renal function or metallic hazards)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01821924

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Raymond Y. Kwong, MD, Principal Investigator, Brigham and Women's Hospital Identifier: NCT01821924     History of Changes
Other Study ID Numbers: 2011P000643
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: April 1, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases