Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors

Recruiting

• Conditions: Immune Checkpoint Inhibitor; Cardiovascular Complication; Cancer; Immune-related Adverse Event

• Registration Number: NCT05799898
• Lead Sponsor: Institut Mutualiste Montsouris

Brief Summary

Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors.

Longitudinal prospective single center cohort. Inclusion criteria: all patient willing to particiupate seen in the cardio-oncology unit at our institution for the suspicion of heart failure, atherosclerosis related event, Tako Tsubo, arrhymias, pericarditis, myocarditis on antiPD1, antiPDL1, or antiCTLA4 immune checkpoint inhibitors.

Description of patients characteristics, investigations, diagnosis after multidisciplinary meeting, outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study First Posted: 2023-04-05
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-07-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major cardiovascular event	12 months	Composite endpoint: acute coronary syndrome, myocarditis, pericarditis, heart failure, Taki Tsubo, ventricvular arrhymias

Trial Locations

Locations (1)

Intitut Mutualiste Montsouris; 🇫🇷 Paris, France