Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease (STIMULUS-CKD)
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.
研究概览
研究类型
介入性
注册 (估计的)
165
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rosa Maria BRUNO, Professor
- 电话号码：+33 1 53 98 79 67
- 邮箱：rosa-maria.bruno@inserm.fr
学习地点
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-
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Paris、法国、75015
- INSERM U970, Equipe 7, 56 rue Leblanc
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接触：
- Rosa Maria BRUNO, Pr
- 电话号码：+33 1 53 98 79 67
- 邮箱：rosa-maria.bruno@inserm.fr
-
首席研究员：
- Rosa Maria BRUNO, Pr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
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.
|
|
实验性的：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.
|
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.
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.
|
|
实验性的：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.
|
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.
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.
|
|
实验性的：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.
|
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.
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.
|
|
实验性的：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.
|
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.
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HEMI-derived small vessel pressure at baseline
大体时间：Baseline (single study visit, approximately 60 minutes)
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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.
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Baseline (single study visit, approximately 60 minutes)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月15日
初级完成 (估计的)
2028年3月15日
研究完成 (估计的)
2028年9月15日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.