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NCT Number: NCT05799898

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

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.

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Key information

Conditions

Cancer Cardiovascular Complication Immune Checkpoint Inhibitor Immune-related Adverse Event Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

No intervention for research purposes only

Other

No intervention for research purposes only

Primary outcomes

  1. Major cardiovascular event

    Time frame: 12 months

    Composite endpoint: acute coronary syndrome, myocarditis, pericarditis, heart failure, Taki Tsubo, ventricvular arrhymias

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Sauret

CONTACT

[email protected]

+33156616705

Nathalie Bass

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Registry information

Official study title

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

Acronym: FAST-TRACK

Important dates

Study start
2022
Primary completion
2023
Study completion
2030
First posted
Apr 5, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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