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Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG (CALM)

31. oktober 2026 opdateret af: China National Center for Cardiovascular Diseases

Cardiac Autonomic Neuromodulation in Myocardial Revascularization (CALM): A Multicenter Randomized Controlled Trial of Partial Cardiac Denervation for the Prevention of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting

Postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery and is associated with increased risks of mortality, stroke, myocardial infarction, and hospital readmission. The cardiac autonomic nervous system plays an important role in the development of POAF and may represent a potential target for preventive intervention.

The CALM trial is a multicenter, randomized controlled trial designed to evaluate the efficacy and safety of partial cardiac denervation for the prevention of POAF in patients undergoing isolated coronary artery bypass grafting (CABG). A total of approximately 1,470 participants will be randomly assigned in a 1:1 ratio to undergo CABG with partial cardiac denervation or CABG alone. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad.

The trial will evaluate the incidence of POAF within the first 6 postoperative days and the occurrence of long-term adverse clinical events. Participants will undergo scheduled rhythm monitoring and clinical follow-up, and all participants will be followed until the last enrolled participant completes 3 years of follow-up after surgery.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass grafting (CABG) and is associated with increased risks of stroke, myocardial infarction, prolonged hospitalization, and other adverse outcomes. Autonomic imbalance and excessive activation of the intrinsic cardiac autonomic nervous system are considered important contributors to the development of POAF. Previous studies of pharmacological or biological autonomic modulation have shown variable efficacy, and their effects may be transient.

A previous single-center randomized trial conducted by the investigators showed that partial cardiac denervation, consisting of transection of the ligament of Marshall and resection of the Waterston fat pad, reduced the incidence of POAF after CABG without increasing perioperative complications. The CALM trial is designed to evaluate whether these findings can be reproduced across multiple centers and to investigate the potential long-term clinical and autonomic effects of this intervention.

This is a prospective, multicenter, randomized controlled trial involving approximately 1,470 patients undergoing isolated CABG with or without cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to partial cardiac denervation in addition to standard CABG or to standard CABG alone. Centralized randomization will be stratified by participating center and baseline CHA2DS2-VASc score. Treatment allocation will be disclosed to the operating surgeon only after induction of anesthesia. Participants, outcome assessors, electrocardiographic reviewers, clinical event adjudicators, and statisticians will remain blinded to treatment allocation.

In the intervention group, the ligament of Marshall, located between the left atrial appendage and the left pulmonary veins, will be transected using electrocautery. The Waterston fat pad, located in the interatrial groove between the right atrium and the right pulmonary veins, will then be completely resected down to the epicardial surface. No additional denervation procedure will be performed in the control group. Other aspects of CABG and perioperative care will follow routine clinical practice at each participating center.

Continuous electrocardiographic monitoring will be performed during the early postoperative period, and scheduled ambulatory electrocardiographic monitoring will be conducted during follow-up. Electrocardiographic recordings will be centrally reviewed by an independent ECG Core Laboratory. Suspected clinical endpoint events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Participants will undergo scheduled clinical follow-up for assessment of arrhythmias, cardiac autonomic function, and long-term clinical outcomes. All participants will be followed until the last enrolled participant has completed 3 years of follow-up after surgery.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
1470

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.
  • Navn: Ziang Yang, M.D.
  • Telefonnummer: 86+19801109287
  • E-mail: yzang47@163.com

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100000
        • Fuwai Hospital, PUMC & CAMS
        • Kontakt:
        • Ledende efterforsker:
          • Wei Feng, M.D.
        • Ledende efterforsker:
          • Zhan Hu, M.D.
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Guangdong Provincial People's Hospital
        • Kontakt:
          • Qiang Gao, M.D.
    • Henan
      • Zhenzhou, Henan, Kina, 451464
        • Fuwai Central China Cardiovascular Hospital
        • Kontakt:
          • Junlong Hu, M.D.
    • Hunan
      • Changsha, Hunan, Kina, 410011
        • The Second Xiangya Hospital of Central South University
        • Kontakt:
          • Xiaobo Liao, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210006
        • Nanjing First Hospital, Nanjing Medical University
        • Kontakt:
          • Fei Xiang, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Scheduled to undergo isolated coronary artery bypass grafting, either with or without cardiopulmonary bypass.
  • Able and willing to provide written informed consent.
  • No atrial fibrillation detected on preoperative 24-hour electrocardiographic monitoring.

Exclusion Criteria:

  • Previous cardiac surgery.
  • Emergency surgery.
  • Preoperative critical condition.
  • Left ventricular ejection fraction of 30% or lower.
  • Left atrial diameter greater than 50 mm.
  • Prior history of atrial fibrillation.
  • Use of antiarrhythmic medications other than beta-blockers within 2 weeks before surgery.
  • Planned concomitant cardiac procedures, including but not limited to congenital heart disease surgery or left ventricular reconstruction.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Ingen indgriben: Control group

CABG alone
Eksperimentel: Intervention group

Partial cardiac denervation + CABG. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad.
Procedure: Partial Cardiac Denervation

The intervention has been described in previous studies. Briefly, intraoperative partial cardiac denervation is achieved by transection of the left LOM and resection of the right Waterston fat pad using electrocautery.

During the procedure, the pulmonary trunk is first gently retracted to the right to expose the LOM located between the left atrial appendage and the left pulmonary veins. The LOM is then transected using electrocautery. Subsequently, the right atrium is retracted to the left to expose the Waterston fat pad located in the interatrial groove. The Waterston fat pad is completely excised with electrocautery down to the epicardial surface.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Atrial Fibrillation Within 6 Postoperative Days
Tidsramme: From admission to the intensive care unit after surgery until postoperative day 6.

The proportion of participants with documented new-onset postoperative atrial fibrillation (POAF). POAF is defined as an episode of atrial fibrillation characterized by irregularly irregular RR intervals and the absence of discernible P waves, lasting more than 30 seconds. Continuous electrocardiographic recordings will be centrally reviewed by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Time to First Occurrence of the Composite Clinical Outcome
Tidsramme: From surgery until 3 years after enrollment of the last participant, with a minimum follow-up of 3 years for each participant.

Time from surgery to the first occurrence of any component of the composite outcome, including all-cause death, stroke, systemic embolism, myocardial infarction, readmission for cardiac reasons, or post-discharge atrial fibrillation. Suspected clinical events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Post-discharge atrial fibrillation events will be reviewed by the blinded ECG Core Laboratory.
From surgery until 3 years after enrollment of the last participant, with a minimum follow-up of 3 years for each participant.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Length of Hospital Stay
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The number of days from the date of surgery to hospital discharge.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Total Hospitalization Costs
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

Total medical costs incurred during the index hospitalization.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative All-Cause Mortality
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The proportion of participants who die from any cause during the perioperative hospitalization.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative New-Onset Stroke
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The proportion of participants who experience a new-onset stroke during the perioperative hospitalization, as adjudicated by the blinded Clinical Event Adjudication Committee according to predefined endpoint criteria.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative Myocardial Infarction
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The proportion of participants who experience myocardial infarction during the perioperative hospitalization, as adjudicated by the blinded Clinical Event Adjudication Committee according to predefined endpoint criteria.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Postoperative Atrial Fibrillation Burden Within 6 Postoperative Days
Tidsramme: From admission to the intensive care unit after surgery until postoperative day 6.

The proportion of analyzable electrocardiographic monitoring time spent in atrial fibrillation during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Number of Postoperative Atrial Fibrillation Episodes Within 6 Postoperative Days
Tidsramme: From admission to the intensive care unit after surgery until postoperative day 6.

The total number of documented postoperative atrial fibrillation episodes per participant during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Duration of Postoperative Atrial Fibrillation Within 6 Postoperative Days
Tidsramme: From admission to the intensive care unit after surgery until postoperative day 6.

The cumulative duration of documented postoperative atrial fibrillation episodes during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Incidence of Post-Discharge Atrial Fibrillation
Tidsramme: From discharge until the end of study follow-up, with a minimum follow-up of 3 years for each participant.

The proportion of participants with atrial fibrillation documented after discharge by scheduled 3-day ambulatory electrocardiographic monitoring or by clinically obtained electrocardiographic recordings. All suspected events will be reviewed by the blinded ECG Core Laboratory.
From discharge until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Post-Discharge Atrial Fibrillation Burden
Tidsramme: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

The proportion of analyzable ambulatory electrocardiographic monitoring time spent in atrial fibrillation during each scheduled 3-day monitoring period, as determined by the blinded ECG Core Laboratory.
At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Non-Atrial Fibrillation Arrhythmias
Tidsramme: From surgery until the end of study follow-up, with a minimum follow-up of 3 years for each participant.

The proportion of participants with predefined non-atrial fibrillation arrhythmias, including third-degree atrioventricular block, frequent premature atrial contractions, and frequent premature ventricular contractions, as determined by the blinded ECG Core Laboratory.
From surgery until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Heart Rate Variability Parameters
Tidsramme: During the first 6 postoperative days and at 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

Cardiac autonomic function will be assessed using time-domain and frequency-domain heart rate variability parameters obtained from electrocardiographic monitoring. Measurements will be centrally analyzed by the blinded ECG Core Laboratory.
During the first 6 postoperative days and at 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Tidsramme: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). An EQ-5D-5L health utility index will be calculated using the Chinese population value set. The index ranges from -0.391 to 1.000, with higher scores indicating better health status. A score of 1.000 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death. Scores will be compared between the two treatment groups at scheduled follow-up assessments.
At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Atrial Fibrillation-Related Quality of Life Assessed Using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire
Tidsramme: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

Atrial fibrillation-related quality of life will be assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT). The AFEQT Overall Summary Score ranges from 0 to 100, with higher scores indicating better atrial fibrillation-related health status and quality of life and lower scores indicating greater impairment. Scores will be compared between the two treatment groups at scheduled follow-up assessments.
At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Reoperation for Bleeding
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).

The proportion of participants who require surgical re-exploration because of postoperative bleeding.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Postoperative Blood Transfusion
Tidsramme: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).

The proportion of participants who receive a blood transfusion after surgery during the index hospitalization.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Delayed Moderate or Greater Pericardial Effusion
Tidsramme: From discharge from the index hospitalization through 30 days after discharge.

The proportion of participants who develop new-onset moderate or greater pericardial effusion within 30 days after discharge from the index hospitalization, as documented by echocardiography.
From discharge from the index hospitalization through 30 days after discharge.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
China National Center for Cardiovascular Diseases

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Chinese Academy of Medical Sciences

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Mario Gaudino, M.D., Weill Medical College of Cornell University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. december 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
31. december 2030

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
31. december 2030

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
23. oktober 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
31. oktober 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
5. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
31. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • NCRC2026001
  • 2026-12M-SXZX1-05 (Andet bevillings-/finansieringsnummer: Chinese Academy of Medical Sciences)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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