Role of Stress CMR in Predicting Adverse Clinical Events in Patients With Known or Suspected IHD

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 2347

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite outcome measure consisting of cardiovascular mortality and nonfatal MI after index CMR.	"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).	target follow up of at least 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite outcome measure consisting of cardiovascular mortality, nonfatal MI, hospitalization for unstable angina or congestive heart failure, and late unplanned coronary bypass surgery at at least 6 months after index CMR.	"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.	target follow up of at least 4 years

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• Shah R, Heydari B, Coelho-Filho O, Murthy VL, Abbasi S, Feng JH, Pencina M, Neilan TG, Meadows JL, Francis S, Blankstein R, Steigner M, di Carli M, Jerosch-Herold M, Kwong RY. Stress cardiac magnetic resonance imaging provides effective cardiac risk reclassification in patients with known or suspected stable coronary artery disease. Circulation. 2013 Aug 6;128(6):605-14. doi: 10.1161/CIRCULATIONAHA.113.001430. Epub 2013 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2012
• Primary Completion (Actual): January 30, 2016
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: March 27, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimated): April 1, 2013

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2011P000643

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No