Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning (HMA)
Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)
Aneurysmal subarachnoid hemorrhage (SAH) is a severe form of stroke caused by bleeding around the brain. Despite early treatment of the initial hemorrhage, many patients develop delayed cerebral ischemia several days later, which is a major cause of neurological disability, cognitive impairment, and mortality. Current preventive and therapeutic strategies are only partially effective, highlighting the need for new treatment approaches.
This study investigates a simple, non-invasive technique called remote ischemic preconditioning (RIPC). RIPC consists of brief, repeated cycles of limb ischemia and reperfusion induced by a blood pressure cuff. RIPC is thought to activate endogenous protective mechanisms that may improve the brain's tolerance to ischemia. Although beneficial effects have been reported in experimental models and cardiovascular diseases, its clinical efficacy in aneurysmal SAH remains uncertain.
In this randomized, controlled, single-blinded, multicenter study, adult patients admitted with aneyrysmal SAH will be randomly assigned to receive RIPC or a sham procedure. The RIPC group will undergo cycles of brief lower-limb ischemia using a pressure cuff, while the sham group will receive an identical procedure without inducing ischemia. Patients and neurologists assessing outcomes will remain blinded to group allocation.
The intervention will be performed every two days from day 2 to day 10 after hemorrhage. Neurological outcome will be assessed at 3 months using the modified Rankin Scale. Secondary outcomes include mortality at 3 months, long-term neurological and cognitive function outcomes at 12 months, and the incidence of adverse events related to the procedure.
If effective, RIPC could become a simple, low-cost, widely accessible method to reduce disability after SAH. The results may help improve future treatment strategies for this severe condition.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Jacques Sedat, MD
- 電話番号:+33 4 92 03 38 07
- メール:sedat.j@chu-nice.fr
研究連絡先のバックアップ
- 名前:Eve Ledoux
- 電話番号:+33 4 92 03 27 29
- メール:ledoux.e@chu-nice.fr
参加基準
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
説明
Inclusion Criteria:
- Age over 18 years
- Hospitalization for aneurysmal subarachnoid hemorrhage confirmed by CT scan and/or lumbar puncture
- Confirmation of intracranial aneurysm by CT angiography and/or cerebral angiography
- Written informed consent obtained from the patient or legal representative
- Affiliation to a social security system
Exclusion Criteria:
- Skin, orthopedic, or vascular conditions of the limbs contraindicating ischemic preconditioning (e.g., ulcers, fractures, deep vein thrombosis)
- Pregnancy
- Withdrawal of informed consent
研究計画
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Ischemic Preconditioning (RIPC)
|
Three cycles of lower-limb ischemia and reperfusion using a blood pressure cuff inflated to 20 mmHg above systolic blood pressure for 5 minutes followed by 5 minutes of reperfusion.
The procedure is performed every two days from day 2 to day 10 after aneurysmal subarachnoid hemorrhage.
|
|
プラセボコンパレーター:Sham Procedure
|
Identical procedure to the experimental arm, except the cuff is inflated to only 30 mmHg, insufficient to induce ischemia, giving the sensation of pressure without therapeutic effect.
Performed every two days from day 2 to day 10 post-hemorrhage.
|
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 |
|---|---|---|
|
Neurological Functional Outcome at 3 Months (mRS)
時間枠:3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
|
Assessment of neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist.
The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
|
3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of mortality at 3 Months
時間枠:From day 0 to 3 months post-hemorrhage
|
Comparison of all-cause mortality between the RIPC group and the sham group
|
From day 0 to 3 months post-hemorrhage
|
|
Long-term Neurological Outcome at 12 Months (mRS)
時間枠:12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
Assessment of long-term neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist.
The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
|
12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
|
Evaluation of Cognitive Function at 12 months (MMSE)
時間枠:12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
Evaluation of cognitive performance assessed using the Mini-Mental State Examination (MMSE).
The MMSE score ranks from 0 to 30, with 30 being a normal congnitive performance and 0 serious cognitive impairments.
|
12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
|
Evaluation of Cognitive Function at 12 months (MoCA)
時間枠:12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
Evaluation of cognitive performance assessed using the Montreal Cognitive Assessment (MoCA).
The MoCA is scored out of 30 points, with high scores suggesting mild or no cognitive impairments, and low scores severe cognitive impairments.
|
12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
|
Safety Outcomes
時間枠:From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
|
Incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.
|
From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 24-AOI-04
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
米国FDA規制機器製品の研究
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