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
Qualifiers
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
Treatments tested in this trial
- Insertion of IABP in SCAI SHOCK stage B
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
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