Cardiogenic ShockIABP ON-TIMENCT06414187
Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock
A study testing Intra-Aortic Balloon Pump in people with Cardiogenic Shock, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this randomized controlled trial is to appraise the impact of intra-aortic balloon pump (IABP) in the treatment of early stages of cardiogenic shock, irrespective of etiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Intra-Aortic Balloon Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age;
- Stage B cardiogenic shock (presence of hypotension or tachycardia with signs of venous congestion, in absence of tissue hypoperfusion) OR
- Stage C cardiogenic shock (evidence of tissue hypoperfusion requiring any intervention beyond fluid management, still responsive to therapy) AND
- Must include at least one of the following: 1) lactate levels at least 2.0 mmol/L; 2) creatinine doubling OR >50 percent decline in glomerular filtration rate compared to baseline; 3) laboratory markers indicating liver injury (e.g. high serum transaminase levels) or 4) elevated NT-pro BNP.
- A patient is eligible for trial inclusion if, at the time of randomization, no more than 1 inotropic agent has been administered AND when the maximum dose of noradrenaline/norepinephrine has not exceeded 0.2 ug/kg/min in the context of mean arterial pressure >65 mmHg.
Who cannot join
- The patient is in cardiogenic shock but does not fulfill the definition for stage B or C;
- Administration of at least 2 inotropic or vasopressive agents at study randomization;
- Administration of noradrenaline/norepinephrine exceeding 0.2 ug/kg/min at study randomization;
- Suspected or known mechanical complication contributing to cardiogenic shock, e.g. ventricular septal defect or papillary muscle rupture;
- Cardiogenic shock developing within 72 hours of a surgical procedure (i.e. low cardiac output with an inability to wean cardiopulmonary bypass);
- Inability to provide informed consent. Of not: patients admitted in cardiogenic shock who required cardiopulmonary resuscitation earlier, but are conscious at the time of hospital admission, are eligible for study participation;
Show all 13Show fewer
- Known or suspected insufficiency of the aortic valve with at least moderate aortic regurgitation;
- Known or suspected peripheral arterial disease preventing safe insertion of IABP;
- Known or suspected thoracic or abdominal aortic disease (including aortic dissection or aortic aneurysm) precluding safe insertion of IABP;
- Suspicion of sepsis or septic shock (including septic cardiomyopathy);
- Pregnancy;
- Predicted life expectancy <6 months because of concomitant disease;
- Concurrent participation in a clinical trial with competing endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus University Medical Center
Rotterdam, South Holland, 3000 CA
Antoon JM van den Enden, +31 70 308896, a.vandenenden@erasmusmc.nl
Nicolas M Van Mieghem, Prof MD PhD
About this study
Official title: Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock: a Multicenter Randomized Controlled Trial
The goal of this randomized controlled trial is to appraise the impact of intra-aortic balloon pump (IABP) in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock.
The main questions it aims to answer are:
Read more
- What are the effects of IABP on a composite of clinical endpoints representing clinical deterioration at 30-days in patients presenting with SCAI stage B or C cardiogenic shock?
- What is the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with vs. without IABP for early cardiogenic shock?
- Is there a difference in efficacy of IABP within the treatment of early cardiogenic shock related to Acute Coronary Syndrome versus non-ischemic causes?
- Is there a difference in efficacy of IABP within the treatment of SCAI stage B versus stage C cardiogenic shock?
Participants will be 1:1 randomized to IABP support or standard of care (a treatment strategy including inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for Acute Coronary Syndrome/non-ischemic etiology and stage B/stage C cardiogenic shock, following stratification to center. Researchers will compare the group who was randomized to IABP to the control group (i.e. standard of care) to see if there is a difference in the primary trial endpoint after 30-days, including 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support strategy, 4) acute kidney injury and 5) stroke or transient ischemic attack.
Read the detailed description
Rationale: The scientific underpinning for the use of mechanical circulatory support (MCS) in early cardiogenic shock, especially for the intra-aortic balloon pump (IABP), is scarce and insufficiently clarified for different etiologies of cardiogenic shock. Previous randomized trials limited the inclusion criteria to patients with ischemic cardiogenic shock while observational research suggested favorable effects of timely adoption of IABP in patients with deteriorating myocardial function through ischemic or non-ischemic causes. Early stage of cardiogenic shock is defined by relative hypotension without hypoperfusion, or hypoperfusion still responsive to therapy (Society for Cardiovascular Angiography and Interventions, SCAI, stage B and C, respectively). A tightening of global guidelines with respect to the clinical adoption of IABP overshadowed the potential beneficial effects for specific patient categories within the total spectrum of cardiogenic shock. Patients currently presenting with early stages of cardiogenic shock caused by ischemic or non-ischemic etiology are hypothetically undertreated due to an assumed lack of clinical benefit of IABP in general. The aim of this randomized trial is to appraise the impact of IABP in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock.
Objective: The primary objective of this trial is to evaluate the 30-day clinical impact of IABP within the treatment of early (SCAI stage B or C) cardiogenic shock. Secondary objectives are
- To evaluate the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with IABP for early cardiogenic shock; 2) To identify differences in efficacy of IABP in the treatment of early cardiogenic shock related to Acute Coronary Syndrome (ACS) versus non-ischemic causes; 3) To explore differences in efficacy of IABP in the treatment of stage B versus stage C cardiogenic shock.
Trial design: Open-label, multicenter, investigator-initiated, randomized controlled trial.
Trial population: The trial population consists of patients in early cardiogenic shock, defined as SCAI stage B or C, either related or unrelated to ACS.
Intervention: Patients enrolled in this trial will be 1:1 randomized to IABP support or standard of care (i.e. inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C cardiogenic shock following stratification according to center.
- Conditions
- Cardiogenic Shock
- Being tested
- Intra-Aortic Balloon Pump
- Keywords
- Intra-aortic balloon pump, Mechanical circulatory support, Acute coronary syndrome, Ischemic cardiogenic shock, Non-ischemic cardiogenic shock, Cardiogenic shock, Decompensated heart failure
- Medical subject headings
- Shock, Cardiogenic, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Aortic Balloon PumpDevice
Patients who are randomized to the IABP-arm will be supported with IABP according to local, clinical guidelines (including algorithms for anticoagulation, verification of correct positioning and weaning strategies). The IABP console and disposables should be used according to the instructions for use, including the use of an appropriate-sized IABP balloon alligned with patient length and height.
| Study group | Role | What they receive |
|---|---|---|
| IABP-arm | Experimental | Patients assigned IABP therapy will undergo IABP insertion as promptly as possible, with a target interval from randomization to insertion of less than 30 minutes. Implantation of the IABP balloon can be established either in the cardiac catheterization laboratory or at bedside in the ICU or cardiac care unit. The steering committee of this trial recommends the use of an appropriate-sized IABP balloon according to the instructions for use.
Low-dose vasopressors (noradrenaline/norepinephrine up to 0.2 ug/kg/min) are allowed next to IABP support. The necessity of increasing the noradrenaline/norepinephrine dose with at least 0.2 ug/kg/min or the necessity to initiate de-novo inotropic agents to reach a mean arterial blood pressure of at least 65 mmHg is considered treatment escalation. Receives: Device: Intra-Aortic Balloon Pump |
| Standard of care-arm | No intervention | When a patient is randomized to the standard of care-arm, the definitive treatment strategy is up to the discretion of the treating physician (providing no IABP is inserted). The treatment strategy may include fluid management as well as administration of inotropes and vasopressors. The only imposed difference in treatment is the omission of IABP, as the dose of inotropes and vasopressors is not expected to be high in early cardiogenic shock. The final decision to escalate in the strategy of mechanical circulatory support (including to initiate IABP in the standard of care-arm) is up to the discretion of the treating physician. However, the steering committee feels escalation in MCS strategy is appropriate in case of persistent mean arterial pressure <65 mmHg with incessant lactate levels >5.0 mmol/L when pharmacologic support was already intensified (e.g. the noradrenaline/norepinephrine dose exceeds 0.2 ug/kg/min or inotropic support was already administered). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint (percent)
The primary endpoint of the trial is the composite of the following outcomes: 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support, 4) acute kidney injury and 5) stroke or transient ischemic attack.
Measured: 30-days post enrollment
Secondary outcomes (13)
All-cause mortality (i.e. the individual determinants of the composite primary outcome) (percent)
See primary outcome (%) (based on details stated in patient's records)
Measured: 30-day follow-up
Escalation to invasive mechanical ventilation (i.e. the individual determinants of the composite primary outcome
See primary outcome (%) (based on details stated in patient's records)
Measured: 30-day follow-up
Escalation to mechanical circulatory support (i.e. the individual determinants of the composite primary outcome)
See primary outcome (%) (based on details stated in patient's records)
Measured: 30-day follow-up
Acute kidney injury (i.e. the individual determinants of the primary outcome)
See primary outcome (%) (based on details stated in patient's records)
Measured: 30-day follow-up
Stroke or transient ischemic attack (i.e. the individual determinants of the primary outcome)
See primary outcome (%) (based on details stated in patient's records)
Measured: 30-day follow-up
Treatment escalation (percent)
Any steps in noradrenaline increase at least 0.2 ug/kg/min, or intensifying inotropic treatment (i.e. dose increasing or initiation of new agents) are considered treatment escalation, irrespective of trial arm. Uptitration of noradrenaline up to 0.2 ug/kg/min is considered standard of care. Treatment escalation also includes the initiation of MCS (including the institution of IABP in the standard of care-arm or escalation to e.g. continuous flow or extracorporeal mechanical circulatory support in the IABP-arm).
Measured: 30-day follow-up
Deterioration of SCAI stage B to C (percent)
If the patient entered the trial meeting criteria for SCAI stage B
Measured: 30-day follow-up
Deterioration of cardiogenic shock (percent)
Degradation to SCAI stage D or E
Measured: at 7 and 14 days after randomization
Vascular complications defined according to VARC-3 guidelines (percent)
Following randomization to the IABP-arm, specifying major and minor vascular complications as well as major and minor access-related non-vascular complications
Measured: 30-day follow-up
Major bleeding complications defined according to BARC guidelines (at least type 2) (percent)
Following randomization to the IABP-arm
Measured: 30-day follow-up
De-novo Acute Coronary Syndrome (percent)
i.e. type 1 myocardial infarction
Measured: 30-day and 1-year follow-up
Cardiopulmonary resuscitation or defibrillation (percent)
Including an appropriate shock of an Implantable Cardioverter Defibrillator
Measured: 30-day follow-up
Development of SIRS, sepsis or severe sepsis (percent)
Defined according to the Surviving Sepsis Guidelines
Measured: 96-hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled in this trial will be 1:1 randomized to IABP support or standard of care (i.e. inotropes and/or vasopressors, but no IABP insertion). Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C cardiogenic shock following stratification according to center.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arrow International LCC (Subsidiary of Teleflex Inc.)
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas M Van Mieghem, Prof MD PhD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414187
- Sponsor's protocol ID
- IABP ON-TIME
- Acronym
- IABP ON-TIME
- Status last verified
- May 2024
- First submitted
- 3 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06414187
- Acronym / sponsor ID
- IABP ON-TIME / IABP ON-TIME
- Conditions
- Cardiogenic Shock
- Keywords
- Intra-aortic balloon pump, Mechanical circulatory support, Acute coronary syndrome, Ischemic cardiogenic shock, Non-ischemic cardiogenic shock, Cardiogenic shock, Decompensated heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Arrow International LCC (Subsidiary of Teleflex Inc.)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to appraise the impact of intra-aortic balloon pump (IABP) in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock.
The main questions it aims to answer are:
- What are the effects of IABP on a composite of clinical endpoints representing clinical deterioration at 30-days in patients presenting with SCAI stage B or C cardiogenic shock?
- What is the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with vs. without IABP for early cardiogenic shock?
- Is there a difference in efficacy of IABP within the treatment of early cardiogenic shock related to Acute Coronary Syndrome versus non-ischemic causes?
- Is there a difference in efficacy of IABP within the treatment of SCAI stage B versus stage C cardiogenic shock?
Participants will be 1:1 randomized to IABP support or standard of care (a treatment strategy including inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for Acute Coronary Syndrome/non-ischemic etiology and stage B/stage C cardiogenic shock, following stratification to center. Researchers will compare the group who was randomized to IABP to the control group (i.e. standard of care) to see if there is a difference in the primary trial endpoint after 30-days, including 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support strategy, 4) acute kidney injury and 5) stroke or transient ischemic attack.
Detailed description
Rationale: The scientific underpinning for the use of mechanical circulatory support (MCS) in early cardiogenic shock, especially for the intra-aortic balloon pump (IABP), is scarce and insufficiently clarified for different etiologies of cardiogenic shock. Previous randomized trials limited the inclusion criteria to patients with ischemic cardiogenic shock while observational research suggested favorable effects of timely adoption of IABP in patients with deteriorating myocardial function through ischemic or non-ischemic causes. Early stage of cardiogenic shock is defined by relative hypotension without hypoperfusion, or hypoperfusion still responsive to therapy (Society for Cardiovascular Angiography and Interventions, SCAI, stage B and C, respectively). A tightening of global guidelines with respect to the clinical adoption of IABP overshadowed the potential beneficial effects for specific patient categories within the total spectrum of cardiogenic shock. Patients currently presenting with early stages of cardiogenic shock caused by ischemic or non-ischemic etiology are hypothetically undertreated due to an assumed lack of clinical benefit of IABP in general. The aim of this randomized trial is to appraise the impact of IABP in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock.
Objective: The primary objective of this trial is to evaluate the 30-day clinical impact of IABP within the treatment of early (SCAI stage B or C) cardiogenic shock. Secondary objectives are
- To evaluate the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with IABP for early cardiogenic shock; 2) To identify differences in efficacy of IABP in the treatment of early cardiogenic shock related to Acute Coronary Syndrome (ACS) versus non-ischemic causes; 3) To explore differences in efficacy of IABP in the treatment of stage B versus stage C cardiogenic shock.
Trial design: Open-label, multicenter, investigator-initiated, randomized controlled trial.
Trial population: The trial population consists of patients in early cardiogenic shock, defined as SCAI stage B or C, either related or unrelated to ACS.
Intervention: Patients enrolled in this trial will be 1:1 randomized to IABP support or standard of care (i.e. inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C cardiogenic shock following stratification according to center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients enrolled in this trial will be 1:1 randomized to IABP support or standard of care (i.e. inotropes and/or vasopressors, but no IABP insertion). Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C cardiogenic shock following stratification according to center.
| Arm | Type | Receives |
|---|---|---|
| IABP-arm | Experimental | Device: Intra-Aortic Balloon PumpPatients assigned IABP therapy will undergo IABP insertion as promptly as possible, with a target interval from randomization to insertion of less than 30 minutes. Implantation of the IABP balloon can be established either in the cardiac catheterization laboratory or at bedside in the ICU or cardiac care unit. The steering committee of this trial recommends the use of an appropriate-sized IABP balloon according to the instructions for use. Low-dose vasopressors (noradrenaline/norepinephrine up to 0.2 ug/kg/min) are allowed next to IABP support. The necessity of increasing the noradrenaline/norepinephrine dose with at least 0.2 ug/kg/min or the necessity to initiate de-novo inotropic agents to reach a mean arterial blood pressure of at least 65 mmHg is considered treatment escalation. |
| Standard of care-arm | No intervention | –When a patient is randomized to the standard of care-arm, the definitive treatment strategy is up to the discretion of the treating physician (providing no IABP is inserted). The treatment strategy may include fluid management as well as administration of inotropes and vasopressors. The only imposed difference in treatment is the omission of IABP, as the dose of inotropes and vasopressors is not expected to be high in early cardiogenic shock. The final decision to escalate in the strategy of mechanical circulatory support (including to initiate IABP in the standard of care-arm) is up to the discretion of the treating physician. However, the steering committee feels escalation in MCS strategy is appropriate in case of persistent mean arterial pressure <65 mmHg with incessant lactate levels >5.0 mmol/L when pharmacologic support was already intensified (e.g. the noradrenaline/norepinephrine dose exceeds 0.2 ug/kg/min or inotropic support was already administered). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age;
- Stage B cardiogenic shock (presence of hypotension or tachycardia with signs of venous congestion, in absence of tissue hypoperfusion) OR
- Stage C cardiogenic shock (evidence of tissue hypoperfusion requiring any intervention beyond fluid management, still responsive to therapy) AND
- Must include at least one of the following: 1) lactate levels at least 2.0 mmol/L; 2) creatinine doubling OR >50 percent decline in glomerular filtration rate compared to baseline; 3) laboratory markers indicating liver injury (e.g. high serum transaminase levels) or 4) elevated NT-pro BNP.
- A patient is eligible for trial inclusion if, at the time of randomization, no more than 1 inotropic agent has been administered AND when the maximum dose of noradrenaline/norepinephrine has not exceeded 0.2 ug/kg/min in the context of mean arterial pressure >65 mmHg.
Key exclusion criteria (13 listed)
- The patient is in cardiogenic shock but does not fulfill the definition for stage B or C;
- Administration of at least 2 inotropic or vasopressive agents at study randomization;
- Administration of noradrenaline/norepinephrine exceeding 0.2 ug/kg/min at study randomization;
- Suspected or known mechanical complication contributing to cardiogenic shock, e.g. ventricular septal defect or papillary muscle rupture;
- Cardiogenic shock developing within 72 hours of a surgical procedure (i.e. low cardiac output with an inability to wean cardiopulmonary bypass);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-Aortic Balloon PumpPatients who are randomized to the IABP-arm will be supported with IABP according to local, clinical guidelines (including algorithms for anticoagulation, verification of correct positioning and weaning strategies). The IABP console and disposables should be used according to the instructions for use, including the use of an appropriate-sized IABP balloon alligned with patient length and height. | Device | IABP-arm |
Primary outcome
Composite primary endpoint (percent)
Time frame: 30-days post enrollment
The primary endpoint of the trial is the composite of the following outcomes: 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support, 4) acute kidney injury and 5) stroke or transient ischemic attack.
13 secondary outcomes
All-cause mortality (i.e. the individual determinants of the composite primary outcome) (percent)
Time frame: 30-day follow-up
Escalation to invasive mechanical ventilation (i.e. the individual determinants of the composite primary outcome
Time frame: 30-day follow-up
Escalation to mechanical circulatory support (i.e. the individual determinants of the composite primary outcome)
Time frame: 30-day follow-up
Acute kidney injury (i.e. the individual determinants of the primary outcome)
Time frame: 30-day follow-up
Stroke or transient ischemic attack (i.e. the individual determinants of the primary outcome)
Time frame: 30-day follow-up
Treatment escalation (percent)
Time frame: 30-day follow-up
Deterioration of SCAI stage B to C (percent)
Time frame: 30-day follow-up
Deterioration of cardiogenic shock (percent)
Time frame: at 7 and 14 days after randomization
Vascular complications defined according to VARC-3 guidelines (percent)
Time frame: 30-day follow-up
Major bleeding complications defined according to BARC guidelines (at least type 2) (percent)
Time frame: 30-day follow-up
De-novo Acute Coronary Syndrome (percent)
Time frame: 30-day and 1-year follow-up
Cardiopulmonary resuscitation or defibrillation (percent)
Time frame: 30-day follow-up
Development of SIRS, sepsis or severe sepsis (percent)
Time frame: 96-hours after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas M Van Mieghem, Prof MD PhD study chair
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Aortic Balloon Pump in people with Cardiogenic Shock, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoon JM van den Enden, MD (+31 10 7038896, a.vandenenden@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (percent) (time frame: 30-days post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.