Stress CMR With Vasodilators to Predict Long-Term Mortality

NCT07191574 | Active Not Recruiting

• 1 other identifier: Registry: RMC_Stress
• Study Type: observational
• Target: 5,552
• Locations: 1 country
• Sites: 1

Brief Summary

Objective We investigated the value of stress cardiac magnetic resonance (CMR) imaging with vasodilators for predicting long-term all-cause mortality in patients with known or suspected ischemic heart disease, using data from a large 15-year registry. Materials and Methods A total of 5,552 consecutive patients with known or suspected ischemic heart disease were included in a registry. They had been referred by their attending cardiologists for clinically indicated stress CMR with vasodilators between 2001 and 2016. All patients provided written informed consent prior to undergoing CMR. At the time of the CMR, clinical characteristics and both segmental and global CMR findings were collected. The presence and extent of stress-induced ischemia were recorded. The study hypothesis is that the presence of ischemia detected by stress CMR is associated with increased long-term all-cause mortality. The study will also explore whether CMR-related revascularization (triggered by ischemia on CMR and performed within the following three months) is associated with reduced long-term mortality. Clinical and CMR data were collected prospectively. Event follow-up will be conducted retrospectively for the purposes of this project through a review of patients' electronic medical records, following approval by the institutional ethics committee. Expected Results This study aims to provide conclusive evidence regarding the utility of stress CMR in predicting the most serious clinical outcome: all-cause mortality. It will also offer valuable insights into the potential therapeutic implications of CMR findings in terms of mortality reduction, depending on test results and subsequent management strategies. The large patient registry enables us to retrospectively address these key clinical questions, contributing to a more rational use of stress cardiac magnetic resonance and a more personalized approach to patient care.

Conditions

Ischemic Heart Disease (IHD); Magnetic Resonance

Keywords

Stress cardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

• Number of Participants with All-cause Mortality as Assessed by Electronic Health Records.

  Primary: All-cause mortality, defined as death from any cause during long-term follow-up, assessed through retrospective review of electronic health records (ORION, ABUCASIS) and adjudicated by consensus of two independent cardiologists. Secondary: Cardiac death, defined as death due to acute myocardial infarction, congestive heart failure, malignant arrhythmias, or cardiac arrest, assessed with the same method. Exploratory: Revascularization related to CMR (procedures performed within 3 months after CMR and directly triggered by its results); myocardial ischemic burden (number of segments with perfusion defects during vasodilator stress CMR); left ventricular ejection fraction (percentage of end-diastolic volume ejected during systole); and myocardial necrosis extent (presence and extent of late gadolinium enhancement). Imaging outcomes analyzed using validated cardiovascular imaging software (Syngo, Siemens).

  up to 15 years

Study Arms (1)

Patients with known or suspected ischemic heart disease

Patients with known or suspected ischemic heart disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective registry that includes all consecutive patients referred by their responsible cardiologists for stress cardiac magnetic resonance imaging with vasodilators for clinical indication in the CMR Unit between January 2001 and December 2016.

You may qualify if:

• known or suspected ischemic heart disease
• stress vasodilator cardiac magnetic resonance imaging study
• written informed consent to undergo the stress vasodilator cardiac magnetic resonance imaging study

You may not qualify if:

• insufficient image quality
• incomplete study

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• Instituto de Investigacion Sanitaria INCLIVA: collaborator

Study Sites (1)

INCLIVA Instituto de Investigación Sanitaria

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: January 1, 2025
• Primary Completion: January 31, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)