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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06020651
Other study ID # CARDIO 05 2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date June 1, 2025

Study information

Verified date July 2023
Source Institut Mutualiste Montsouris
Contact Isabelle Sauret, MBS
Phone +33 1 56 61
Email isabelle.sauret@imm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date. The VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing: - surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve) as defined by the International Cardio-Oncology Society; - circulating biomarkers Before and after receiving ICIs for solid cancer treatment.


Description:

Context. Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date. Endothelial dysfunction is a predictor of the development of atherosclerotic plaque and events related to erosion or rupture. Endothelial dysfunction correlates well with the increase of circulating microparticles in various populations. The increase of circulating microparticles is also associated with major cardiovascular events. The International society of Cardio-Oncology (IC-OS) recently published a definition for subclinical vascular toxicities due to ICIs. It includes non-invasive imaging methods readily available at the bedside (Herrmann et al. European Heart Journal 2022), largely replicated in the recent European Society of Cardiology (ESC) guidelines 2022. It includes the decrease of flow mediated reserve <7% or hyperhemia index <2; or the decrease of any of these biomarkers > 50% from baseline. Aims and Methods. The VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing: - surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve, hyperhemia index, plaque volume) as defined by IC-OS; - circulating microparticles; Before and after receiving ICIs for solid cancer treatment. The number of participants: - 40 patients receiving ICIs for solid cancer (alone or in combination of other cancer drugs); - 40 controls (matched by age, gender, cancer type) not treated by ICIs. Duration of participation: up to 6 weeks. Inclusion period: 12 months. Perspectives. The VICKI study may improve our understanding of the mechanisms of atherosclerosis mediated major cardiovascular events. If circulating biomarkers correlate well with Doppler surrogate markers of vascular toxicity, larger studies to refine prediction models could be undertaken. This would be a step forward personalized care for the prediction of major cardiovascular events on ICIs.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 1, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients scheduled for first ICI therapy at our institution; - Matched controls with cancer and no ICI therapy; Exclusion Criteria: - Major cardiovascular event in the past 6 months; - Unable to provide informed consent; - History of ICI therapy

Study Design


Intervention

Diagnostic Test:
Arterial Doppler for Flow Mediated Reserve measurement
Arterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs

Locations

Country Name City State
France INstitut Mutualiste Montsouris Paris

Sponsors (2)

Lead Sponsor Collaborator
Institut Mutualiste Montsouris Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial dysfunction Surrogate marker of endothelial dysfunction : Signifiant FMD variation on ICIs as defined by the International Cardio-Oncology Society 6 weeks
Secondary Correlation of blood biomarkers to endothelial dysfunction (surrogate marker: Flow Mediated Dilatation variation) Increase in microparticles (CD144+, CD31+/41-, CD62e+, CD235a+, CD41+, CD11+, CD3+); cytokines (e.g., IL-1b, IFNg, TNFa, VEGF-A, C, D, HGF); single-cell profiling and deep immunophenotyping. 6 weeks
Secondary Major cardiovascular event (MACE) Collection of clinically relevant MACE at clinical follow-up: acute coronary syndrome; coronary angioplasty; stroke; cardiac suddent death, myocarditis, myositis. 6 months
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