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Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock (DOUBLE-SHOCK)

20. august 2026 opdateret af: Leipzig Heart Science gGmbH

Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock

The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).

The main questions it aims to answer are:

  • Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?
  • Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?

Researchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients:

  • Microaxial flow pump + pulmonary artery catheter
  • Microaxial flow pump + conventional monitoring
  • Medical therapy alone + pulmonary artery catheter
  • Medical therapy alone + conventional monitoring

Participants will:

  • Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups
  • Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI
  • Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring
  • Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years

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.

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.
780

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.

Studiesteder

  • Tyskland
    • Saxony
      • Leipzig, Saxony, Tyskland, 04289
        • Heart Center Leipzig at University of Leipzig

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:

  1. Planned immediate angiography and revascularization (preferred PCI)
  2. Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
  3. Arterial lactate >2.0 mmol/L
  4. Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm

Exclusion Criteria:

  1. Age <18 and >80 years
  2. Shock duration >12 hours
  3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
  4. Shock due to mechanical complication of AMI
  5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression >10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression <10 min are also eligible)
  6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion
  7. Any unwitnessed OHCA
  8. Refractory cardiac arrest with ongoing chest compression
  9. Evidence of severe right ventricular failure
  10. Severe aorta valve regurgitation/stenosis
  11. Severe peripheral arterial obstructive disease precluding mAFP placement
  12. Abnormalities of the aorta precluding mAFP device placement
  13. Presence of a mechanical aortic valve prosthesis
  14. Left ventricular thrombus
  15. Infective endocarditis
  16. Life expectancy <1 year due to comorbidities
  17. Mental disorder or language barrier that preclude informed consent
  18. Known pregnancy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

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.
Eksperimentel: Microaxial flow pump + pulmonary artery catheter
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Enhed: Microaxial flow pump (left ventricular assist device)
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI.
Enhed: Pulmonary artery catheter
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
Eksperimentel: Microaxial flow pump + conventional monitoring
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted.
Enhed: Microaxial flow pump (left ventricular assist device)
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI.
Procedure: Conventional hemodynamic monitoring
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
Aktiv komparator: Medical therapy + pulmonary artery catheter
Participants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Enhed: Pulmonary artery catheter
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
Procedure: Hemodynamic stabilization
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
Aktiv komparator: Medical therapy + conventional monitoring
Participants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. All participants receive standard intensive care treatment as clinically indicated.
Procedure: Conventional hemodynamic monitoring
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
Procedure: Hemodynamic stabilization
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.

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
all-cause death
Tidsramme: 180 days after randomization
The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized.
180 days after randomization

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
Lactate clearance
Tidsramme: 48 hours
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
48 hours
Time to normalization of lactate
Tidsramme: from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
Time in hours to stable normalization of arterial lactate <2 mmol/l.
from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
Time to hemodynamic stabilization
Tidsramme: Time to hemodynamic stabilization from randomization up to 4 weeks.
Time to hemodynamic stabilization from randomization up to 4 weeks.
Need for escalation to (additional) MCS
Tidsramme: from date of randomization up to 4 weeks
Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.
from date of randomization up to 4 weeks
Vasoactive-inotropic score (VIS)
Tidsramme: from randomization to ICU discharge which usually occurs within 4 weeks
The score has no metric; higher values indicate worse outcomes.
from randomization to ICU discharge which usually occurs within 4 weeks
Need for cardio-pulmonary resuscitation
Tidsramme: from date of randomization up to 4 weeks
Number of patients requiring cardiopulmonary resuscitation.
from date of randomization up to 4 weeks
Length of intensive care unit stay
Tidsramme: from date of randomization to usually up to 4 weeks.
Length of intensive care unit stay in days
from date of randomization to usually up to 4 weeks.
Length of hospitalization
Tidsramme: from date of randomization to usually up to 6 months
Length of hospital stay in days
from date of randomization to usually up to 6 months
Quality of life (EuroQol 5D-5L)
Tidsramme: 6month, 12 month after randomisation
Quality of life measured by the EuroQol 5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
6month, 12 month after randomisation
Time to recurrent myocardial infarction
Tidsramme: From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
Time to rehospitalization for congestive heart failure
Tidsramme: during the first 30 days, 6 and 12 months after randomization
during the first 30 days, 6 and 12 months after randomization
Time to death
Tidsramme: during the first 30 days and 12 months after randomization
during the first 30 days and 12 months after randomization
Use of heart replacement therapy
Tidsramme: from date of randomization up to 6 months.
Need for heart replacement therapy
from date of randomization up to 6 months.
Mortality and heart failure events
Tidsramme: at 6 and 12 months
death, permanent LVAD/HTx and heart failure hospitalization
at 6 and 12 months
Implantable defibrillator
Tidsramme: from date of randomization up to 12 months.
Need for implantable cardiac defibrillator
from date of randomization up to 12 months.
Health-related costs
Tidsramme: from date of randomization to 6 months
Health related costs in € for each intervention.
from date of randomization to 6 months
Mortality
Tidsramme: From randomization to death from any cause, assessed annually up to 10 years after randomization
From randomization to death from any cause, assessed annually up to 10 years after randomization

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sustained ventricular arrhythmia requiring cardioversion
Tidsramme: from date of randomization up to usually 4 weeks
Sustained ventricular arrhythmia requiring cardioversion
from date of randomization up to usually 4 weeks
Bradycardia with pacing requirement
Tidsramme: from date of randomization up to usually 4 weeks.
Bradycardia requiring pacing.
from date of randomization up to usually 4 weeks.
Acute kidney injury according to KDIGO criteria
Tidsramme: from date of randomization up to usually 4 weeks.
Acute kidney injury according to KDIGO criteria
from date of randomization up to usually 4 weeks.
Creatinine clearance (assessed by eGFR)
Tidsramme: From randomization to 72 hours after randomization
From randomization to 72 hours after randomization
Requirement for renal replacement therapy
Tidsramme: from date of randomization up to usually 4 weeks.
Acute kidney injury requiring renal replacement therapy.
from date of randomization up to usually 4 weeks.
Major bleeding according to BARC definition (BARC 3-5)
Tidsramme: from date of randomization up to usually 4 weeks
Major bleeding according to BARC 3-5 criteria.
from date of randomization up to usually 4 weeks
Cumulative transfusion need
Tidsramme: from date of randomization up to 4 weeks.
Number of red packed blood cells for transfusion per patient .
from date of randomization up to 4 weeks.
Vascular access site related complications
Tidsramme: from date of randomization up to 4 weeks.
Number of vascular access site related complications.
from date of randomization up to 4 weeks.
Significant hemolysis
Tidsramme: from date of randomization up to usually 4 weeks.

Significant hemolysis is defined as a plasma free hemoglobin >20 mg/dL (or an increase of 20 mg/dL above baseline values before initiation of support) and at least one of the following clinical findings occurring within 72 hours after initiation of support or within 24 (±2) hours of device removal:

  • Presence of hemoglobinuria ("tea-colored urine") with exclusion of gross hematuria
  • New or worsening anemia defined as an absolute decrease in hematocrit by 10% or hemoglobin level by 3 g/dL not explained by other clinical factors.
  • Hyperbilirubinemia defined as a total bilirubin above 2 mg/dl (predominately indirect component)
  • Creatinine increasing by greater than 50% above baseline or the need for new dialysis not explained by other clinical factors.
  • Device malfunction or abnormal pump parameters
from date of randomization up to usually 4 weeks.
Sepsis with positive blood cultures
Tidsramme: from date of randomization up to usually 4 weeks.

Sepsis is defined as: Sepsis is caused by the immune system's response to a serious infection, most commonly bacteria, but also fungi, viruses, and parasites in the blood, urinary tract, lungs, skin, or other tissues. It will be defined as:

Positive blood cultures and two or more of the following (SEPSIS-3 criteria):

  1. Low blood pressure (SBP ≤100 mmHg),
  2. High respiratory rate (≥22 breaths per min), or
  3. Altered mentation (Glasgow coma scale <15) (quick SOFA)
from date of randomization up to usually 4 weeks.
Stroke
Tidsramme: from date of randomization up to usually 4 weeks.

Stroke will be classified in hemorrhagic (cranial CT, MRI, or autopsy) or non-hemorrhagic.

Stroke is defined as an acute new neurological deficit ending in death or lasting longer than 24 hours, and classified by a physician as a stroke.

  1. Primary hemorrhagic - defined as an intracerebral hemorrhage or subdural hematoma

    1. Intracerebral hemorrhage - Stroke with focal collections of intracerebral blood seen on brain imaging (CT or MRI) or a post-mortem examination, not felt to represent hemorrhagic conversion. Subarachnoid hemorrhage should be included in this category.
    2. Subdural hematoma - High density fluid collection in subdural space on brain images or blood in the subdural space on autopsy.
  2. Non-hemorrhagic cerebral infarction - Stroke without focal collections of intracerebral blood on brain imaging.
  3. Non-hemorrhagic infarction with hemorrhagic conversion - Cerebral infarction with blood felt to represent hemorrhagic
from date of randomization up to usually 4 weeks.
Thrombocytopenia
Tidsramme: from date of randomization up to 4 weeks.
Thrombocytopenia is defined as platelet count <50,000 platelets per microliter.
from date of randomization up to 4 weeks.
Device malfunction
Tidsramme: from date of randomization up to 4 weeks.
from date of randomization up to 4 weeks.

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.
Leipzig Heart Science gGmbH

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.
Boston Scientific Corporation
University of Southern Denmark
Heart Center Leipzig - University Hospital
Stiftung Institut fuer Herzinfarktforschung

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Holger Thiele, Prof. Dr. med., Heart Center Leipzig at University of Leipzig
  • Ledende efterforsker: Jacob Eifer Møller, Prof DMSc, Copenhagen University Hospital Righospitalet
  • Ledende efterforsker: Christian Hassager, Prof. DMSc, Rigshospitalet, Denmark
  • Ledende efterforsker: Anne Freund, PD Dr. med., Heart Center Leipzig at Leipzig 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. oktober 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.
1. oktober 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.
1. april 2037

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).
3. juli 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.
7. august 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.
13. august 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.
24. august 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.
20. august 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. august 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.
  • DOUBLE-SHOCK Trial

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.

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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