Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock

NCT06414187 | Not Yet Recruiting DMC

• 1 other identifier: IABP ON-TIME
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30-days post enrollment

Secondary Outcomes (13)

• All-cause mortality (i.e. the individual determinants of the composite primary outcome) (percent)

  30-day follow-up

• Escalation to invasive mechanical ventilation (i.e. the individual determinants of the composite primary outcome

  30-day follow-up

• Escalation to mechanical circulatory support (i.e. the individual determinants of the composite primary outcome)

  30-day follow-up

• Acute kidney injury (i.e. the individual determinants of the primary outcome)

  30-day follow-up

• Stroke or transient ischemic attack (i.e. the individual determinants of the primary outcome)

  30-day follow-up

Other Outcomes (11)

• Mortality (percent)

  30-day follow-up and 1-year follow-up

• Length of intensive care unit and hospital stay (in days)

  30-day follow-up

• Re-admission to the intensive care unit (percent)

  30-day follow-up

Study Arms (2)

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.

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).

Interventions

Intra-Aortic Balloon Pump DEVICE

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.

IABP-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Arrow International LCC (Subsidiary of Teleflex Inc.): collaborator

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Acute Coronary Syndrome

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Nicolas M Van Mieghem, Prof MD PhD

  Erasmus Medical Center

  STUDY CHAIR

Central Study Contacts

Antoon JM van den Enden, MD

CONTACT

+31 10 7038896; a.vandenenden@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Given the nature of percutaneous IABP support a double-blind trial design is not feasible. Therefore, this trial is an open-label randomized clinical trial indicating both the patient, treating physicians as well as researchers are aware of the allocated treatment (i.e. with or without IABP). The Clinical Event Committee (CEC), responsible for adjudicating events belonging to e.g. the primary outcome, are blinded for the allocated treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Full Professional, Clinical Director of Interventional Cardiology

Model Details: 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 Record Dates

• First Submitted: January 3, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

NL (1)