Fast-Track Cardiovascular Assessment for Suspicion of Car... | NCT05799898

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Jan 1, 2030Estimated

First Submitted Date

Mar 23, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2023

Last Update Posted Date

Apr 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention for research purposes only	Other	No intervention for research purposes only

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults on immune checkpoint inhibitors for cancer treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isabelle Sauret	Contact	+33156616705		isabelle.sauret@imm.fr
Nathalie Bass	Contact			nathalie.bass@imm.fr

Overall Officials

Name	Affiliation	Role
Mariana Mirabel, MD, PhD	Institut Mutualiste Montsouris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intitut Mutualiste Montsouris	Recruiting	Paris		75014	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.