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NCT05799898 Clinical Trial

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

Cancer Clinical Trial

— FAST-TRACK  

Official title:
Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05799898
Other study ID # CARDIO-03-2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date January 1, 2030

Study information
Verified date March 2023
Source Institut Mutualiste Montsouris
Contact Isabelle Sauret
Phone +33156616705
Email isabelle.sauret@imm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 1, 2030
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention for research purposes only
No intervention for research purposes only

Locations
Country Name City State
France Intitut Mutualiste Montsouris Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major cardiovascular event Composite endpoint: acute coronary syndrome, myocarditis, pericarditis, heart failure, Taki Tsubo, ventricvular arrhymias 12 months
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