NCT07267884Toborzás még nem indult
IABP for MI-VSD Patients in SCAI SHOCK Stage B
Evaluation of the Effectiveness and Safety of Intra-Aortic Balloon Pump Insertion in Patients With Ventricular Septal Defect Following Myocardial Infarction During SCAI SHOCK Stage B: A Multicenter, Randomized, Open-Label, Parallel Controlled Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 19.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2025. szept. 30.
- Kezdés
- 2026. febr. 28.
- Elsődleges befejezés
- 2028. febr. 28.
- Fő szponzor
- Qilu Hospital of Shandong University
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07267884
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 100
- 2026. febr. 28. és az elsődleges befejezés (2028. febr. 28.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Chronic end-stage organ dysfunction that is not expected to be suitable for surgical treatment;
- Refusal to sign the informed consent form, disagreement to insert IABP, or no willingness to proceed with further surgical treatment.
Más betegség
- Congenital heart disease with ventricular septal defect;
- 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);
- Aortic valve insufficiency more than grade II, aortic dissection or aneurysm cannot be ruled out;
- Difficulty in implanting IABP due to severe peripheral vascular disease or other reasons;
Életkor
- Age > 75 years;
Egyéb
- Complications such as free wall rupture, papillary muscle dysfunction, etc.;
- Shock caused by other reasons (such as sepsis or hypovolemia);
- Patients with an expected life span of less than 12 months;
- Pregnancy and lactation;
Kiket keres a vizsgálat
- 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;
- Obtain informed consent.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Department of Cardiology, Qilu Hospital of Shandong University | Jinan | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.