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Condizionamento ischemico remoto per ictus ischemico acuto trattato con trombectomia meccanica(RECAST-MT) (RECAST-MT)

4 novembre 2026 aggiornato da: Ji Xunming,MD,PhD, Capital Medical University

Sicurezza ed efficacia del condizionamento ischemico remoto per l'ictus ischemico acuto trattato con trombectomia meccanica (RECAST-MT): uno studio multicentrico, randomizzato, controllato, in aperto, in cieco

For patients with acute ischemic stroke caused by large vessel occlusion, endovascular thrombectomy has been demonstrated to be the most effective therapy, as approximately 90% of the occluded vessels can be recanalized. However, less than 50% of patients could achieve functional independence, and over 15% died 90 days after stroke. Although the mismatch of successful recanalization with poor prognosis can be attributed to many factors, the infarct core formed during thrombectomy and reperfusion injury after thrombectomy may be among the most important and effective neuroprotective strategies urgently needed.

Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confer protection against prolonged and severe ischemia in distant organs. In the transient focal cerebral ischemia-reperfusion model, the application of remote ischemic conditioning before reperfusion or both before and after reperfusion reduces reperfusion injuries and the final infarct size. Because patients with acute ischemic stroke who are treated with endovascular thrombectomy can achieve a high rate of recanalization after focal ischemia, this patient population is akin to the model of transient focal cerebral ischemia-reperfusion. Furthermore, a pilot study has determined the safety and feasibility of remote ischemic conditioning in patients undergoing endovascular thrombectomy. However, whether remote ischemic conditioning could provide clinical benefits to patients with acute ischemic stroke who are treated with endovascular thrombectomy urgently needs investigations.

This study aims to investigate the safety and efficacy of remote ischemic conditioning in improving functional outcomes of patients with acute ischemic stroke treated with endovascular thrombectomy and explore the effect of treatment duration on the treatment outcome of remote ischemic conditioning.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

2105

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xunming Ji, MD, PhD
  • Numero di telefono: 010-8319-9439
  • Email: jixm@ccmu.edu.cn

Backup dei contatti dello studio

Luoghi di studio

      • Beijing, Cina, 100053
        • Reclutamento
        • Xuanwu Hospital, Capital Medical University
        • Contatto:
        • Contatto:
      • Beijing, Cina, 100020
        • Reclutamento
        • Beijing Chao-Yang Hospital
        • Contatto:
          • Yang Wang
      • Beijing, Cina, 100049
        • Reclutamento
        • Aerospace Central Hospital
        • Contatto:
          • Peifu Wang
      • Beijing, Cina, 100071
        • Reclutamento
        • Beijing Fengtai You'anmen Hospital
        • Contatto:
          • Jing Wang
      • Beijing, Cina, 100085
        • Reclutamento
        • Beijing Red Cross Emergency Medical Center
        • Contatto:
          • Guohui Zhao
      • Beijing, Cina, 102600
        • Reclutamento
        • Beijing Daxing District People's Hospital
        • Contatto:
          • Jinglin Yuan
      • Chongqing, Cina, 408000
        • Non ancora reclutamento
        • Chongqing University Fuling Hospital
        • Contatto:
          • Tao Wang
    • Anhui
      • Suzhou, Anhui, Cina, 234000
        • Reclutamento
        • Suzhou Municipal Hospital of Anhui Province
        • Contatto:
          • Lei Zhang
      • Taihe Chengguanzhen, Anhui, Cina, 236600
        • Reclutamento
        • Taihe County People's Hospital
        • Contatto:
          • Tao Cui
      • Tongling, Anhui, Cina
        • Reclutamento
        • Tongling People's Hospital
        • Contatto:
          • Tao Wang
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100010
        • Reclutamento
        • Beijing Fangshan District First Hospital
        • Contatto:
          • Liang Chen
      • Beijing, Beijing Municipality, Cina, 100000
        • Reclutamento
        • Beijing Luhe Hospital affiliated to Capital Medical University
        • Contatto:
          • Xiaokun Geng
    • Fujian
      • Fuzhou, Fujian, Cina, 350028
        • Non ancora reclutamento
        • Fujian Provincial Hospital
        • Contatto:
          • Qiong Cheng
      • Zhangzhou, Fujian, Cina, 363000
        • Reclutamento
        • Zhangzhou Municipal Hospital of Fujian Province
        • Contatto:
          • Tingyu Yi
    • Guangdong
      • Heyuan, Guangdong, Cina, 517000
        • Reclutamento
        • Heyuan People's Hospital
        • Contatto:
          • Guanghong Zhong
      • Huizhou, Guangdong, Cina, 516000
        • Reclutamento
        • Huizhou Third People's Hospital
        • Contatto:
          • Jinjin Yan
      • Shenzhen, Guangdong, Cina, 518000
        • Non ancora reclutamento
        • Shenzhen Second People's Hospital
        • Contatto:
          • Pengcheng Fu
      • Shenzhen, Guangdong, Cina, 518000
        • Reclutamento
        • South China Hospital Affiliated to Shenzhen University
        • Contatto:
          • Shiwei Du
    • Guangxi
      • Nanning, Guangxi, Cina, 530000
        • Reclutamento
        • The Second Nanning People's Hospital
        • Contatto:
          • Tong Li
      • Qinzhou, Guangxi, Cina, 535000
        • Reclutamento
        • Qinzhou Second People's Hospital
        • Contatto:
          • Caixia Xuan
    • Hainan
      • Haikou, Hainan, Cina, 570100
        • Reclutamento
        • The Second Affiliated Hospital of Hainan Medical University
        • Contatto:
          • Bin Chen
    • Hebei
      • Cangzhou, Hebei, Cina, 061000
        • Reclutamento
        • Cangzhou Central Hospital
        • Contatto:
          • Yongchang Liu
      • Shijiazhuang, Hebei, Cina, 050047
        • Reclutamento
        • Army Medical University Noncommissioned Officer School Affiliated Hospital
        • Contatto:
          • Jin Li
      • Tangshan, Hebei, Cina, 063000
        • Reclutamento
        • Kailuan General Hospital
        • Contatto:
          • Yesong Liu
    • Heilongjiang
      • Harbin, Heilongjiang, Cina
        • Reclutamento
        • The First Affiliated Hospital of Harbin Medical University
        • Contatto:
          • Hongquan Jiang
      • Jiamusi, Heilongjiang, Cina, 154000
        • Reclutamento
        • The Hongda Hospital of Jiamusi University
        • Contatto:
          • Changsi Ai
    • Henan
      • Hebi, Henan, Cina, 456250
        • Reclutamento
        • Xunxian People's Hospital
        • Contatto:
          • Beihai Jiang
      • Jiaozuo, Henan, Cina, 454000
        • Reclutamento
        • Jiaozuo Coal Industry Group Co., Ltd. Central Hospital
        • Contatto:
          • Qianqian Qiu
      • Luoyang, Henan, Cina, 471000
        • Reclutamento
        • Luoyang Yanshi People's Hospital
        • Contatto:
          • Yang Zhou
      • Luoyang, Henan, Cina, 471000
        • Reclutamento
        • the first people's hospital of Luoyang
        • Contatto:
          • Jinfeng Shi
      • Nanyang, Henan, Cina, 473000
        • Reclutamento
        • Nanyang Central Hospital
        • Contatto:
          • Changming Wen
      • Nanyang, Henan, Cina, 473000
        • Reclutamento
        • Nanyang Nanshi Hospital
        • Contatto:
          • Shuai Zhu
      • Shangqiu, Henan, Cina, 476000
        • Reclutamento
        • Shangqiu First People's Hospital
        • Contatto:
          • Quande Dai
      • Zhengzhou, Henan, Cina, 450000
        • Non ancora reclutamento
        • Henan Province People's Hospital
        • Contatto:
          • Liangfu Zhu
      • Zhoukou, Henan, Cina, 466600
        • Reclutamento
        • Xihua county people's hospital
        • Contatto:
          • Chaoqun Li
    • Hubei
      • Huanggang, Hubei, Cina, 438000
        • Reclutamento
        • Huanggang Central hospital
        • Contatto:
          • Jiajun Wang
      • Huangshi, Hubei, Cina, 435000
        • Reclutamento
        • Huangshi central hospital
        • Contatto:
          • Chensong Deng
      • Jingmen, Hubei, Cina, 448000
        • Reclutamento
        • Jingmen People's Hospital
        • Contatto:
          • Wei Li
      • Jingmen, Hubei, Cina, 448000
        • Reclutamento
        • Jingmen Central hospital
        • Contatto:
          • Ying Wei
      • Tianmen, Hubei, Cina, 430000
        • Sospeso
        • First People's Hospital of Tianmen
      • Wuhan, Hubei, Cina, 430000
        • Reclutamento
        • Zhongnan Hospital of Wuhan University
        • Contatto:
          • Huagang Li
          • Numero di telefono: 8617762473010
      • Wuhan, Hubei, Cina, 430033
        • Non ancora reclutamento
        • The Third People's Hospital of Hubei Province
        • Contatto:
          • Yue Wan
      • Xiangyang, Hubei, Cina
        • Reclutamento
        • Xiangyang Central Hospital
        • Contatto:
          • Jing Yang
      • Yichang, Hubei, Cina, 443000
        • Reclutamento
        • Yichang Central People's Hospital
        • Contatto:
          • Huajun Zhou
    • Hunan
      • Changde, Hunan, Cina, 415000
        • Reclutamento
        • Changde First Hospital of Traditional Chinese Medicine
        • Contatto:
          • Weiwu Hu
      • Changde, Hunan, Cina, 415000
        • Reclutamento
        • the First People's Hospital of Changde
        • Contatto:
          • Jun Wen
      • Changde, Hunan, Cina, 415700
        • Reclutamento
        • Taoyuan County People's Hospital
        • Contatto:
          • Hui Tan
      • Changsha, Hunan, Cina, 410000
        • Reclutamento
        • The Third Xiangya Hospital of Central South University
        • Contatto:
          • Yi Yuan
      • Chenzhou, Hunan, Cina, 423000
        • Non ancora reclutamento
        • the First People's Hospital of Chenzhou
        • Contatto:
          • Xiaoxi Yao
      • Xiangtan, Hunan, Cina, 411100
        • Non ancora reclutamento
        • The Central Hospital of Xiangtan
        • Contatto:
          • Guangxiong Yuan
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Cina, 010000
        • Non ancora reclutamento
        • Inner Mongolia Autonomous Region People's Hospital
        • Contatto:
          • Dong Wang
    • Jiangsu
      • Suzhou, Jiangsu, Cina, 215006
        • Reclutamento
        • The First Affiliated Hospital of Soochow University
        • Contatto:
          • Qi Fang
      • Suzhou, Jiangsu, Cina, 215000
        • Reclutamento
        • The Fourth Affiliated Hospital of Soochow University
        • Contatto:
          • Qi Fang
      • Xuzhou, Jiangsu, Cina, 221000
        • Reclutamento
        • The Affiliated Hospital of Xuzhou Medical University
        • Contatto:
          • Yu Feng
    • Liaoming
      • Dalian, Liaoming, Cina, 116011
        • Reclutamento
        • The First Affiliated Hospital of Dalian Medical University
        • Contatto:
          • Ke Li
    • Liaoning
      • Anshan, Liaoning, Cina, Anshan
        • Reclutamento
        • Anshan Changda Hospital
        • Contatto:
          • Fan Zhang
      • Dalian, Liaoning, Cina, 116000
        • Reclutamento
        • The First Affiliated Hospital of Dalian Medical University
        • Contatto:
          • Ke Li
    • Shandong
      • Dongying, Shandong, Cina, 257000
        • Reclutamento
        • Shengli Oilfield Central Hospital
        • Contatto:
          • Ye Lang
      • Jinan, Shandong, Cina, 250000
        • Reclutamento
        • Jinan Third People's Hospital
        • Contatto:
          • Yan Li
      • Liaocheng, Shandong, Cina, 252000
        • Reclutamento
        • Liaocheng People's Hospital
        • Contatto:
          • Liyong Zhang
      • Liaocheng, Shandong, Cina, 252000
        • Reclutamento
        • Liaocheng Third People's Hospital
        • Contatto:
          • Lei Yang
      • Liaocheng, Shandong, Cina, 252800
        • Reclutamento
        • The People's Hospital of Gaotang
        • Contatto:
          • Huqing Li
      • Linyi, Shandong, Cina, 273400
        • Sospeso
        • Feixian People's Hospital
      • Yantai, Shandong, Cina
        • Reclutamento
        • Yeda Hospital
        • Contatto:
          • Wenjun Qian
    • Shannxi
      • Weinan, Shannxi, Cina, 714000
        • Reclutamento
        • Weinan Central Hospital
        • Contatto:
          • Zhen Yang
    • Sichuan
      • Chengdu, Sichuan, Cina, 610017
        • Reclutamento
        • Chengdu Second People's Hospital
        • Contatto:
          • Jian Wang
      • Mianyang, Sichuan, Cina, 621000
        • Reclutamento
        • Mianyang third people's hospital
        • Contatto:
          • Hongxia Yang
      • Ya'an, Sichuan, Cina, 625000
        • Reclutamento
        • Ya 'an People's Hospital
        • Contatto:
          • Jian Wang
    • Zhejiang
      • Wenzhou, Zhejiang, Cina, 325000
        • Reclutamento
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contatto:
          • Bo Yin
      • Yueqing, Zhejiang, Cina, 325600
        • Reclutamento
        • Yueqing People's Hospital
        • Contatto:
          • Saizhen Wu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Age≥18 years;
  2. Acute ischemic stroke due to large vessel occlusion in the anterior circulation that is not suitable for intravenous thrombolytic therapy, or has contraindications to intravenous thrombolytic therapy, or treated with intravenous thrombolytic therapy without recanalization;
  3. Large vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA), including the occlusion of the intracranial segment of the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA), is the cause of symptoms, and mechanical thrombectomy is planned within 24 hours from the time last known well;
  4. Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;
  5. Patients or family members signed a written informed consent form.

Exclusion Criteria:

  1. Imaging examination revealed the presence of multiple vascular supply areas of cerebral infarction (such as the simultaneous presence of infarction in both anterior and posterior circulation);
  2. Absence of femoral artery pulsation, extremely difficult intravascular access, or extremely tortuous large vessels, which are expected to result in the inability to undergo timely endovascular treatment;
  3. Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;
  4. Coma or lethargy patients (consciousness level score ≥2 in NIHSS);
  5. Unable to obtain an accurate baseline NIHSS score;
  6. Pre-stroke modified Rankin Scale (mRS) score >1;
  7. Baseline ASPECTS score ≤5;
  8. Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR > 3.0;
  9. Baseline blood glucose <2.7mmol/L or >22.2mmol/L;
  10. Baseline platelet count < 30*10^9/L;
  11. Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate <30mL/min;
  12. Cranial CT or MRI shows intracranial hemorrhage;
  13. Cranial CT or MRI shows midline deviation and significant occupying effect;
  14. Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;
  15. History of head injury in the past 3 months;
  16. History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
  17. Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding;
  18. The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
  19. Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
  20. Participating in other ongoing clinical trials;
  21. Other conditions that the investigators believe are not suitable for participation in this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Control group

Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Altri nomi:
  • EVT

Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.

Sperimentale: 14-day treatment group

Patients in the 14-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 14 days post-thrombectomy.

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Altri nomi:
  • EVT

Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.

RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 14 days post-thrombectomy.

Altri nomi:
  • RIC 14 giorni
Sperimentale: 30-day treatment group

Patients in the 30-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 30 days post-thrombectomy.

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Altri nomi:
  • EVT

Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.

RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 30 days post-thrombectomy.

Altri nomi:
  • RIC 30 giorni

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
Lasso di tempo: 90 days after stroke.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

90 days after stroke.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Two dichotomous mRS scores at 90 days (0-1 vs 2-6, 0-3 vs 4-6, 0-4 vs 5-6, 0-5 vs 6).
Lasso di tempo: 90 days after stroke.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

90 days after stroke.
The ordinal distribution of mRS scores at 90 days.
Lasso di tempo: 90 days after stroke.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

90 days after stroke.
The proportion of patients with early neurological improvement 24 hours after endovascular procedures.
Lasso di tempo: 24 hours after endovascular procedures.

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes. Neurological improvement is defined as the NIHSS recovering to ≤2 points or decreasing by 8 points or much higher as compared with the baseline.

24 hours after endovascular procedures.
Changes in NIHSS score from baseline to day 14 or at discharge (whichever comes earlier).
Lasso di tempo: 14 days or at discharge (whichever comes first)

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

14 days or at discharge (whichever comes first)
Score of EQ-5D-5L at 90 days.
Lasso di tempo: 90 days after stroke.

EQ-5D-5L is a tool used to assess health status, including five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A higher score indicates a better health status, while a lower score indicates a poorer health status.

90 days after stroke.
Cerebral infarct volume.
Lasso di tempo: 72 hours after endovascular procedures.

The infarction volume will be assessed on cranial CT or MRI imaging.

72 hours after endovascular procedures.
The change of infarct volume.
Lasso di tempo: 72 hours after endovascular procedures.

Infarct Expansion Ratio (IER, IER=infarct volume/baseline infarct volume). The infarction volume will be assessed on cranial CT or MRI imaging, and baseline infarct volume will be assessed on the CTP or baseline MRI imaging.

72 hours after endovascular procedures.
Incidence of intracranial hemorrhage.
Lasso di tempo: Within 14 days after endovascular procedures.

Intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.

Within 14 days after endovascular procedures.
Incidence of Symptomatic Intracranial Hemorrhage
Lasso di tempo: Within 14 days after endovascular procedures.

Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III).

Within 14 days after endovascular procedures.
Incidence of neurological deterioration within 14 days.
Lasso di tempo: Within 14 days after endovascular procedures.

Neurological deterioration is defined as an increase of ≥4 points in NIHSS compared to before deterioration within 14 days.

Within 14 days after endovascular procedures.
Incidence of malignant infarction
Lasso di tempo: 0-90 days

Malignant infarction is defined as infarction involving more than half of the affected middle cerebral artery area, a significant mass effect requiring decompressive craniectomy, and/or directly leading to death with clinical signs of brain herniation.

0-90 days
All cause of death.
Lasso di tempo: 0-90 days

The incidence of death events at any time from randomization through day 90.

0-90 days
Incidence of Adverse Events/Serious Adverse Events
Lasso di tempo: 0-90 days

The incidence of other adverse events and serious adverse events at any time from randomization through day 90.

0-90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 settembre 2024

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

4 agosto 2024

Primo inviato che soddisfa i criteri di controllo qualità

16 agosto 2024

Primo Inserito (Effettivo)

19 agosto 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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