NCT01821924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2016

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

March 27, 2013

Last Update Submit

November 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    target follow up of at least 4 years

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients above the age of 21 who are clinically referred for stress cardiac MRI.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 1, 2013

Study Start

January 30, 2012

Primary Completion

January 30, 2016

Study Completion

August 30, 2018

Last Updated

November 6, 2025

Record last verified: 2025-11

Locations