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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01821924
• Other study ID #: 2011P000643
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2013
• Last updated: March 29, 2013
• Start date: January 2012

Study information

• Verified date: March 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age >/= 21 years old

• No contraindications for cardiac MRI (by renal function or metallic hazards)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality, MI, heart failure hospitalization or documentation of an LV ejection fraction < 0.40 after index CMR at a follow-up.	"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.	5 years	No