Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414187
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-03
Brief Title:
Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IABP ON-TIME
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 11 randomized to IABP support or standard of care a treatment strategy including inotropes andor vasopressors but no IABP insertion Patients will be stratified for Acute Coronary Syndromenon-ischemic etiology and stage Bstage C cardiogenic shock following stratification to center Researchers will compare the group who was randomized to IABP to the control group ie 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
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 11 randomized to IABP support or standard of care a treatment strategy including inotropes andor vasopressors but no IABP insertion Patients will be stratified for Acute Coronary Syndromenon-ischemic etiology and stage Bstage C cardiogenic shock following stratification to center Researchers will compare the group who was randomized to IABP to the control group ie 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
1 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 11 randomized to IABP support or standard of care ie inotropes andor vasopressors but no IABP insertion Patients will be stratified for ACSnon-ischemic etiology and stage Bstage C cardiogenic shock following stratification according to center
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
1 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 11 randomized to IABP support or standard of care ie inotropes andor vasopressors but no IABP insertion Patients will be stratified for ACSnon-ischemic etiology and stage Bstage C cardiogenic shock following stratification according to center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None