Renal Cell CarcinomaVICKINCT06020651
Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside
A study testing Arterial Doppler for Flow Mediated Reserve measurement in people with Renal Cell Carcinoma and Bladder Cancer, run by Institut Mutualiste Montsouris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Bladder Cancer, MSI-H Cancer
- What is being tested?
- Arterial Doppler for Flow Mediated Reserve measurement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for first ICI therapy at our institution;
- Matched controls with cancer and no ICI therapy;
Who cannot join
- Major cardiovascular event in the past 6 months;
- Unable to provide informed consent;
- History of ICI therapy
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Renal Cell Carcinoma, Bladder Cancer, MSI-H Cancer, Cancer
- Being tested
- Arterial Doppler for Flow Mediated Reserve measurement
- Keywords
- Atherosclerosis, Cancer, Immune Checkpoint Inhibitor, Vascular Diseases
- Medical subject headings
- Carcinoma, Renal Cell, Urinary Bladder Neoplasms, Neoplasms, Atherosclerosis, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Doppler for Flow Mediated Reserve measurementDiagnostic test
Also called Blood sampling
Arterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs
| Study group | Role | What they receive |
|---|---|---|
| ICIs alone | Experimental | Participants on ICIs alone Receives: Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement |
| ICIs + VEGF inhibitors | Experimental | Participants on ICIs + VEGF inhibitors Receives: Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement |
| ICIs + chemotherapy | Experimental | Participants on ICIs + chemotherapy Receives: Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement |
| Controls | Sham comparator | Participants on other than ICIs cancer therapies Receives: Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial dysfunction
Surrogate marker of endothelial dysfunction : Signifiant FMD variation on ICIs as defined by the International Cardio-Oncology Society
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 6 weeks
Major cardiovascular event (MACE)
Collection of clinically relevant MACE at clinical follow-up: acute coronary syndrome; coronary angioplasty; stroke; cardiac suddent death, myocarditis, myositis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start7 Jun 2023
- Primary completion30 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants will undergo the same cardiovascular assessment; only cancer therapies differ according to standard of care.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020651
- Sponsor's protocol ID
- CARDIO 05 2022
- Acronym
- VICKI
- Status last verified
- Apr 2026
- First submitted
- 27 Jul 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside
- ClinicalTrials.gov ID
- NCT06020651
- Acronym / sponsor ID
- VICKI / CARDIO 05 2022
- Conditions
- Renal Cell Carcinoma, Bladder Cancer, MSI-H Cancer, Cancer
- Keywords
- Atherosclerosis, Cancer, Immune Checkpoint Inhibitor, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All participants will undergo the same cardiovascular assessment; only cancer therapies differ according to standard of care.
| Arm | Type | Receives |
|---|---|---|
| ICIs alone | Experimental | Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurementParticipants on ICIs alone |
| ICIs + VEGF inhibitors | Experimental | Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurementParticipants on ICIs + VEGF inhibitors |
| ICIs + chemotherapy | Experimental | Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurementParticipants on ICIs + chemotherapy |
| Controls | Sham comparator | Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurementParticipants on other than ICIs cancer therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients scheduled for first ICI therapy at our institution;
- Matched controls with cancer and no ICI therapy;
Key exclusion criteria (3 listed)
- Major cardiovascular event in the past 6 months;
- Unable to provide informed consent;
- History of ICI therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Doppler for Flow Mediated Reserve measurementAlso: Blood samplingArterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs | Diagnostic test | Controls, ICIs + VEGF inhibitors, ICIs + chemotherapy, ICIs alone |
Primary outcome
Endothelial dysfunction
Time frame: 6 weeks
Surrogate marker of endothelial dysfunction : Signifiant FMD variation on ICIs as defined by the International Cardio-Oncology Society
2 secondary outcomes
Correlation of blood biomarkers to endothelial dysfunction (surrogate marker: Flow Mediated Dilatation variation)
Time frame: 6 weeks
Major cardiovascular event (MACE)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Doppler for Flow Mediated Reserve measurement in people with Renal Cell Carcinoma and Bladder Cancer, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial dysfunction (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.