Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital Identifier:
First received: March 27, 2013
Last updated: March 29, 2013
Last verified: March 2013

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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    "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.

Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01821924

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

No publications provided by Brigham and Women's Hospital

Additional 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
Study First Received: March 27, 2013
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on February 25, 2015