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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease (STIMULUS-CKD)

30 de julho de 2026 atualizado por: Institut National de la Santé Et de la Recherche Médicale, France
This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

165

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
      • Paris, França, 75015
        • INSERM U970, Equipe 7, 56 rue Leblanc
        • Contato:
        • Investigador principal:
          • Rosa Maria BRUNO, Pr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Common Inclusion Criteria:

    • Adults aged over 18 years, of both sexes
    • Patients eligible for or affiliated with a social security scheme
    • Patients who have provided written informed consent to participate in the study

Common Exclusion Criteria:

  • Inability to give informed consent
  • Persons under legal protection (guardianship, trusteeship, or court protection)
  • Language barrier or psychological refusal to read the information
  • Medical conditions with a life expectancy < 1 year according to clinical judgment
  • Ongoing participation restriction due to another clinical research study
  • Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)
  • Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block

Exclusion Criteria:

  • Hypertension Group

    • Inclusion: Prior diagnosis of arterial hypertension
    • Stable cardiovascular treatment in the previous 1 month

    • Exclusion:

      • CKD with GFR <60 mL/min
      • ACR > 30 mg/mmol
      • Type 2 diabetes Type 2 Diabetes Group
    • Inclusion:
    • Prior diagnosis of type 2 diabetes
    • Stable cardiovascular treatment in the previous 1 month

    • Exclusion:

      • CKD with GFR < 60 mL/min
      • ACR > 30 mg/mmol Moderate CKD Group
    • Inclusion:
    • Moderate CKD (eGFR between 30 and 60 mL/min) (CKD-EPI)
    • Patients scheduled for arterial stiffness assessment as part of routine care
    • Stable cardiovascular treatment in the previous 1 month
    • Exclusion:
    • No specific exclusion criteria beyond common exclusions Severe CKD Group

    • Inclusion:

      • Severe CKD (GFR < 30 mL/min for ≥ 2 months)
      • Patients scheduled for arterial stiffness assessment as part of routine care
      • Stable cardiovascular treatment the previous 1 month
    • Exclusion: No specific exclusion criteria beyond common exclusions20 / 48 C25-07_Protocole_ V1.0_01.12.2025 Healthy Volunteers Group
    • Inclusion: No documented chronic disease

    • Exclusion:

      • Moderate or severe CKD (GFR < 60 mL/min) (CKD-EPI)
      • Hypertension
      • Type 2 diabetes
      • Stable cardiovascular treatment in the previous 1 month

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Healthy Volunteers
Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Dispositivo: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Dispositivo: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Hypertension Without Chronic Kidney Disease
Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Dispositivo: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Dispositivo: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Type 2 Diabetes Mellitus Without Chronic Kidney Disease
Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Dispositivo: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Dispositivo: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Moderate Chronic Kidney Disease
Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Dispositivo: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Dispositivo: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Severe Chronic Kidney Disease
Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Dispositivo: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Dispositivo: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
HEMI-derived small vessel pressure at baseline
Prazo: Baseline (single study visit, approximately 60 minutes)
Small vessel pressure derived from the HEMI non-invasive investigational device under standardized resting conditions at baseline. The primary analysis compares values across the five study groups.
Baseline (single study visit, approximately 60 minutes)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Institut National de la Santé Et de la Recherche Médicale, France

Colaboradores

University of Turku
Imec

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de setembro de 2026

Conclusão Primária (Estimado)

15 de março de 2028

Conclusão do estudo (Estimado)

15 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • C25-07

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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