Coronary Artery DiseaseNCT01821924
Role of Stress CMR in Predicting Adverse Clinical Events in Patients With Known or Suspected IHD
An observational study of Coronary Artery Disease, run by Brigham and Women's Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 2,347 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2012to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients above the age of 21 who are clinically referred for stress cardiac MRI.
Who may be able to join
- Age >/= 21 years old
- No contraindications for cardiac MRI (by renal function or metallic hazards)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
"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.
Measured: target follow up of at least 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study start30 Jan 2012
- Primary completion30 Jan 2016
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Y. Kwong, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821924
- Sponsor's protocol ID
- 2011P000643
- Status last verified
- Nov 2025
- First submitted
- 27 Mar 2013
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23804252
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Stress CMR in Predicting Adverse Clinical Events in Patients With Known or Suspected Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT01821924
- Acronym / sponsor ID
- 2011P000643
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,347 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2012 (actual)
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above the age of 21 who are clinically referred for stress cardiac MRI.
Key inclusion criteria (2 listed)
- Age >/= 21 years old
- No contraindications for cardiac MRI (by renal function or metallic hazards)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A composite outcome measure consisting of cardiovascular mortality and nonfatal MI after index CMR.
Time frame: target follow up of at least 4 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).
1 secondary outcome
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.
Time frame: target follow up of at least 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Derived from this study: PubMed 23804252Shah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite outcome measure consisting of cardiovascular mortality and nonfatal MI after index CMR. (time frame: target follow up of at least 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.