Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors (FAST-TRACK)

March 23, 2023 updated by: Institut Mutualiste Montsouris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults on immune checkpoint inhibitors for cancer treatment

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Mutualiste Montsouris

Investigators

  • Principal Investigator: Mariana Mirabel, MD, PhD, Institut Mutualiste Montsouris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CARDIO-03-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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