Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors (TILT)

Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study

Recent guidelines suggest the use of troponin to detect immnune related cardiovascular advserse events in patients treated by immune checkpoint inhibitors for cancer.

However, there is no proof that patients on immune checkpoint inhibitors benefit from this active surveillance strategy. The suspicion of cardiovascular events may lead to the interruption of cancer therapies.

The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic patients to prevent the further advent of major cardiovascular events; (ii) its safety in terms of cancer therapy completion.

Study Overview

• Status: Completed
• Conditions: Cancer; Immune Checkpoint Inhibitor; Cardiovascular Biomarkers
• Intervention / Treatment: Other: No intervention

Detailed Description

Retrospective two-center study comparing two groups of patients on immune checkpoint inhibitors:

• Group 1: active surveillance by serial troponin measures not prompted by cardiovascular symptoms ;
• Group 2: no troponin measures.

For any solid cancer or stage.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Institut Mutualiste Montsouris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult solid cancer patients receiving immune checkpoint inhibitors

Description

Inclusion Criteria:

• All solid cancer patients treated by immune checkpoint inhibitors 2017-2022

Exclusion Criteria:

• Patients enrolled in an invterventional study (e.g., pharma trial)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active surveillance by means of troponin measurements	Other: No intervention; No intervention
No active surveillance by means of troponin measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular event	Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of cancer therapy as scheduled	Cardiovascular contre indication to immune checkpoint inhibitors	5 years

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris
• Collaborators: Institut Curie
• Investigators: Principal Investigator: Mariana Mirabel, MD, PhD, Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CARDIO-04-2022

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