IABP for MI-VSD Patients in SCAI SHOCK Stage B
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
Ventricular septal defect (MI-VSD) is a serious mechanical complication of acute myocardial infarction, with an extremely high mortality. Intra-aortic balloon pump (IABP) is still the most easily available mechanical assistive device for clinical management, and it has become a bridge to surgical repair.
IABP-SHOCK II trial is currently the largest randomized controlled trial (RCT) related to the use of IABP among patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS), the trial found that IABP had a negative impact on 30-day, 1-year, and 6-year all-cause mortality. However, the trial included patients with typical cardiogenic shock (shock stages C-E, SCAI definition criteria), most of whom had severely inadequate microcirculatory perfusion, limiting the effectiveness of IABP treatment.
There is still no clinical study on the usage of IABP in MI-VSD patients with early-stage CS. The main objective of this study is to assess the correlation between the utilization of IABP and 30-day mortality rates among MI-VSD patients with early-stage CS. The investigators will also follow up on the long-term prognosis of these patients. The investigators will enroll multicenter patients with MI-VSD who are at the onset of cardiogenic shock (SCAI SHOCK stage B) to explore the impact of IABP support on the prognosis of these patients.
This prospective, multicenter, randomized, open-label, parallel-group controlled study will involve 100 participants who are diagnosed with MI-VSD complicated by SCAI SHOCK stage B in about 5 centers. After reviewing the inclusion criteria, participants will be randomized to two groups (Early-CS-IABP group and Control group) in a ratio of 1:1. The primary outcome is all-cause mortality within 30 days after MI-VSD. The investigators will also observe 6-month and 1-year all-cause mortality after MI-VSD.
The investigators speculated that IABP could significantly improve the clinical outcomes of patients with MI-VSD if it could be used in the early stage of cardiogenic shock.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years;
Diagnosed with AMI based on clinical manifestations, electrocardiogram, cardiac troponin markers, etc.;
Diagnosis of MI-VSD by echocardiography;
Patients in stage B according to the SCAI shock stage definition before enrollment, meeting the following conditions: (1) good mental status, (2) warm limbs without cold and clammy feeling, (3) Killip class 2, with the beginning of wet rales at the lung bases, (4) arterial blood lactate ≤ 2mmol/L, (5) normal renal function or mild renal impairment (creatinine increase less than 1.5 times baseline or eGFR decrease ≤ 50%), (6) no use of vasoactive drugs;
Disqualifiers
Age > 75 years;
Congenital heart disease with ventricular septal defect;
Complications such as free wall rupture, papillary muscle dysfunction, etc.;
Typical cardiogenic shock (SCAI shock stages C-E) before enrollment, any of the following: (1) altered mental status, (2) cold and clammy skin, (3) Killip class 3 or 4, (4) arterial blood lactate > 2mmol/L, (5) severe liver and kidney function impairment, (6) use of vasoactive drugs to maintain blood pressure; or in shock risk period (stage A);
Trial design
Design model
Parallel
Treatments tested in this trial
Insertion of IABP in SCAI SHOCK stage B
DeviceFor patients in Early-CS-IABP group, IABP will be inserted within 8 hours after admission, along with medical treatment to maintain circulatory stability. Once the Department of Cardiovascular Surgery determines that a patient has surgical indications, he will be transferred to the surgery department for surgical septal repair.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Early-CS-IABP groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
All-cause mortality within 30 days after MI-VSD
Time frame
From enrollment to the 30th day of MI-VSDSecondary outcomes
1
Number of participants who progress to SCAI SHOCK stages C-E
Participants meeting the following criteria will be considered to progress to SCAI SHOCK stages C-E: (1) altered mental status, (2) cold and clammy skin, (3) Killip class 3 or 4, (4) arterial blood gas lactate \> 2 mmol/L, (5) severe liver and kidney function impairment, (6) use of vasoactive drugs to maintain blood pressure. In the case report form, participants with shock progression were recorded as "1" while those without progression were recorded as "0".
Time frame
30 days after MI-VSD2
Number of participants who undergo surgical repair for ventricular septal defect
Determine whether the participants have undergone surgical repair of ventricular septal defect based on the hospital's electronic medical record system. In the case report form, participants who have undergone surgical repair for ventricular septal defect were recorded as "1" while those without surgical repair were recorded as "0".
Time frame
30 days after MI-VSD3
6-month all-cause mortality after MI-VSD
Time frame
From enrollment to 6 months after MI-VSD4
1-year all-cause mortality after MI-VSD
Time frame
From enrollment to 1 year after MI-VSDSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qilu Hospital of Shandong University
Lead sponsor
Shandong Provincial Hospital
Collaborator
Qianfoshan Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Jinan Central Hospital
Collaborator
Source ClinicalTrials.gov
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