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

NCT ID: NCT05799898

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2030-01-01

Brief Summary

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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

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Conditions

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Cancer Immune Checkpoint Inhibitor Cardiovascular Complication Immune-related Adverse Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention for research purposes only

No intervention for research purposes only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Mutualiste Montsouris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariana Mirabel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Locations

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Intitut Mutualiste Montsouris

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle Sauret

Role: CONTACT

+33156616705

Nathalie Bass

Role: CONTACT

Facility Contacts

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Mariana Mirabel, MD, PhD

Role: primary

+33156616479

Isabelle Sauret, MBs

Role: backup

+33156616705

Other Identifiers

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CARDIO-03-2022

Identifier Type: -

Identifier Source: org_study_id

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