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.
調査の概要
研究の種類
介入
入学 (推定)
165
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Rosa Maria BRUNO, Professor
- 電話番号：+33 1 53 98 79 67
- メール：rosa-maria.bruno@inserm.fr
研究場所
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-
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Paris、フランス、75015
- INSERM U970, Equipe 7, 56 rue Leblanc
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コンタクト：
- Rosa Maria BRUNO, Pr
- 電話番号：+33 1 53 98 79 67
- メール：rosa-maria.bruno@inserm.fr
-
主任研究者：
- Rosa Maria BRUNO, Pr
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HEMI-derived small vessel pressure at baseline
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月15日
一次修了 (推定)
2028年3月15日
研究の完了 (推定)
2028年9月15日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月31日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- C25-07
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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