FAST-TRACK: Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors
Sponsor
Institut Mutualiste Montsouris (Other)
Overall Status
Recruiting
CT.gov ID
NCT05799898
Collaborator
(none)
200
1
94.1
2.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.
Actual Study Start Date
:
Mar 1, 2022
Anticipated Primary Completion Date
:
Jul 1, 2023
Anticipated Study Completion Date
:
Jan 1, 2030
Outcome Measures
Primary Outcome Measures
- Major cardiovascular event [12 months]
Composite endpoint: acute coronary syndrome, myocarditis, pericarditis, heart failure, Taki Tsubo, ventricvular arrhymias
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Intitut Mutualiste Montsouris | Paris | France | 75014 |
Sponsors and Collaborators
- Institut Mutualiste Montsouris
Investigators
- Principal Investigator: Mariana Mirabel, MD, PhD, Institut Mutualiste Montsouris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier:
NCT05799898
Other Study ID Numbers:
- CARDIO-03-2022
First Posted:
Apr 5, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No