Assessment of cardiovascular issues in cancer patients on immune checkpoint inhibitors
Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.
This study is trying to see if cancer patients treated with immune checkpoint inhibitors have heart problems and how those issues affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Mutualiste Montsouris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05799898 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate patients who are suspected of experiencing cardiovascular events while undergoing treatment with immune checkpoint inhibitors. It involves a longitudinal prospective cohort design at a single center, where patients referred to the cardio-oncology unit will be assessed for conditions such as heart failure, atherosclerosis, and myocarditis. The study will document patient characteristics, diagnostic investigations, and outcomes following a multidisciplinary review. The goal is to better understand the cardiovascular complications associated with these cancer treatments.
Who should consider this trial
Good fit: Ideal candidates include cancer patients who are being treated with immune checkpoint inhibitors and are experiencing suspected cardiovascular complications.
Not a fit: Patients who are not receiving immune checkpoint inhibitors or do not have suspected cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and monitoring of cardiovascular complications in cancer patients receiving immune checkpoint inhibitors.
How similar studies have performed: While there may be limited studies specifically addressing this combination, the investigation of cardiovascular effects in cancer treatments is an emerging area, suggesting potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors Exclusion Criteria: * none
Where this trial is running
Paris
- Intitut Mutualiste Montsouris — Paris, France (Recruiting)
Study contacts
- Principal investigator: Mariana Mirabel, MD, PhD — Institut Mutualiste Montsouris
- Study coordinator: Isabelle Sauret
- Email: isabelle.sauret@imm.fr
- Phone: +33156616705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.