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 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
780
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: DOUBLE SHOCK Leipzig Heart Science gGmbH
- Telefonnummer: +49 341 865 251542
- E-post: DOUBLE-SHOCK@leipzig-heart.de
Studiesteder
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04289
- Heart Center Leipzig at University of Leipzig
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:
- Planned immediate angiography and revascularization (preferred PCI)
- Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
- Arterial lactate >2.0 mmol/L
- Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm
Exclusion Criteria:
- Age <18 and >80 years
- Shock duration >12 hours
- Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
- Shock due to mechanical complication of AMI
- 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)
- After 390 included patients with OHCA, any OHCA will be an exclusion criterion
- Any unwitnessed OHCA
- Refractory cardiac arrest with ongoing chest compression
- Evidence of severe right ventricular failure
- Severe aorta valve regurgitation/stenosis
- Severe peripheral arterial obstructive disease precluding mAFP placement
- Abnormalities of the aorta precluding mAFP device placement
- Presence of a mechanical aortic valve prosthesis
- Left ventricular thrombus
- Infective endocarditis
- Life expectancy <1 year due to comorbidities
- Mental disorder or language barrier that preclude informed consent
- Known pregnancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
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.
|
|
Eksperimentell: 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.
|
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.
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.
|
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.
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.
|
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).
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lactate clearance
Tidsramme: 48 hours
|
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
|
48 hours
|
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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.
|
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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.
|
|
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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
|
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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
|
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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.
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6month, 12 month after randomisation
|
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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
|
|
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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
|
|
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Time to death
Tidsramme: during the first 30 days and 12 months after randomization
|
during the first 30 days and 12 months after randomization
|
|
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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.
|
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Mortality and heart failure events
Tidsramme: at 6 and 12 months
|
death, permanent LVAD/HTx and heart failure hospitalization
|
at 6 and 12 months
|
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Implantable defibrillator
Tidsramme: from date of randomization up to 12 months.
|
Need for implantable cardiac defibrillator
|
from date of randomization up to 12 months.
|
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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
|
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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
Resultatmål |
Tiltaksbeskrivelse |
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.
|
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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:
|
from date of randomization up to usually 4 weeks.
|
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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):
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from date of randomization up to usually 4 weeks.
|
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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.
|
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.
|
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Device malfunction
Tidsramme: from date of randomization up to 4 weeks.
|
from date of randomization up to 4 weeks.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Holger Thiele, Prof. Dr. med., Heart Center Leipzig at University of Leipzig
- Hovedetterforsker: Jacob Eifer Møller, Prof DMSc, Copenhagen University Hospital Righospitalet
- Hovedetterforsker: Christian Hassager, Prof. DMSc, Rigshospitalet, Denmark
- Hovedetterforsker: Anne Freund, PD Dr. med., Heart Center Leipzig at Leipzig University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. oktober 2030
Studiet fullført (Antatt)
1. april 2037
Datoer for studieregistrering
Først innsendt
3. juli 2026
Først innsendt som oppfylte QC-kriteriene
7. august 2026
Først lagt ut (Faktiske)
13. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DOUBLE-SHOCK Trial
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
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Nei
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