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RecruitingNCT05799898FAST-TRACKUpdated Apr 5, 2023

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

An observational study in Cancer, Immune Checkpoint Inhibitor and Cardiovascular Complication, sponsored by Institut Mutualiste Montsouris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by Institut Mutualiste Montsouris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
  • Immune Checkpoint Inhibitor
  • Cardiovascular Complication
  • Immune-related Adverse Event
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults on immune checkpoint inhibitors for cancer treatment

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherNo intervention for research purposes only

    No intervention for research purposes only

05

What researchers measure

Primary outcomes

  1. Major cardiovascular event

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

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05799898
Lead sponsor
Institut Mutualiste Montsouris
Responsible party
Sponsor
First posted
Apr 5, 2023
Start date
Mar 1, 2022
Primary completion
Jul 1, 2023 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Apr 5, 2023

Study contacts

Isabelle Sauret
Contact
isabelle.sauret@imm.fr
+33156616705
Nathalie Bass
Contact
nathalie.bass@imm.fr
Mariana Mirabel, MD, PhD
principal investigator · Institut Mutualiste Montsouris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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