Kardiobeskyttende virkninger af kardiopeptider til injektion hos patienter med ikke-svær hjertesygdom: et enkeltcenter randomiseret kontrolleret forsøg
29. september 2026 opdateret af: Nanfang Hospital, Southern Medical University
The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
234
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Guangzhou, Kina, 510515
- Southern medical university Nanfang hospital
-
-
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
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:
- Age ≥18 years old
- The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
- Obtain the informed consent of the subject or legal agent
Exclusion Criteria:
- Patients who are expected to die within 48 hours of ICU admission
- previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
- cardiopulmonary resuscitation and/or electrical defibrillation before admission
- patients with acute ischemic stroke
- patients with stage 5 chronic kidney disease
- during pregnancy or breastfeeding
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cardiopeptidin
Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days |
Cardiopeptidin was administered intravenously once a day with cardiopeptidin for 3 days.The dosing regimen follows the recommended dosage of 1 mg/kg/day as outlined in the product manual, with doses calculated based on the ideal body weight. |
|
Placebo komparator: 50 ml of normal saline intravenous infusion
50 ml of normal saline intravenous infusion. |
50 ml of normal saline intravenous infusion |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
major adverse cardiac events
Tidsramme: On the day of enrollment, until 28 days.
|
major adverse cardiac events |
On the day of enrollment, until 28 days.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
28-day all-cause mortality
Tidsramme: 28-day
|
28-day all-cause mortality |
28-day
|
|
90-day all-cause mortality
Tidsramme: 90-day
|
90-day all-cause mortality |
90-day
|
|
Cardiac adverse events
Tidsramme: In hospital, until the patient is discharged.
|
Cardiac adverse events |
In hospital, until the patient is discharged.
|
|
LVEF
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
LVEF |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
APACHE II
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
APACHE II |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
Hypersensitive troponin T
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
MB
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
MB |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
NT-Pro BNP
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
NT-Pro BNP |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
LDH
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
LDH |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
α-HBDH
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
α-HBDH |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
CK
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
CK |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
CKMB
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
CKMB |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
|
Lac
Tidsramme: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
Lac |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: zhenhua zeng, Nanfang Hospital, Southern Medical 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 (Faktiske)
1. marts 2024
Primær færdiggørelse (Faktiske)
12. september 2024
Studieafslutning (Faktiske)
30. december 2024
Datoer for studieregistrering
Først indsendt
14. september 2023
Først indsendt, der opfyldte QC-kriterier
31. oktober 2023
Først opslået (Faktiske)
3. november 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NFEC-2023-060
Plan for individuelle deltagerdata (IPD)
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JA
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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