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A multicenter, prospective study on the clinical characteristics, treatment strategy and prognosis of post-myocardial infarction ventricular septal rupture

A multicenter, prospective study on the clinical characteristics, treatment strategy and prognosis of post-myocardial infarction ventricular septal rupture

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038079
Enrollment
Unknown
Registered
2020-09-09
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventricular septal rupture

Interventions

Conservative treatment group:Drug therapy
Interventional Treatment Group:Transcatheter closure of ventricular septal rupture
Surgical Treatment Group:Surgical treatment for ventricular septal rupture

Sponsors

Fuwai Central China Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Post-admission or in-patient diagnosis of "ventricular Septal perforation after acute myocardial infarction" . Criteria for diagnosis of Ami: Based on the fourth edition of the global definition of myocardial infarction. VSR DIAGNOSTIC CRITERIA: 1) physical examination; 2) echocardiography examination; 3) left ventricular angiography. Of the above 3 diagnostic criteria, the first 2 non-invasive diagnostic tests often established the diagnosis. (2) The patient or his legal guardian has signed an informed consent. (3) Be willing and able to accept 1-year follow-up.

Exclusion criteria

Exclusion criteria: (1) The patients or their family members refused to be included in the group and could not follow the treatment and follow-up without signed informed consent; (2) the perforation diameter >= 20mm or the perforation was not suitable for blocking the adjacent valve, Tendon, etc. ; (3) Except for the perforation of the interventricular Septum, combined with rupture of Free Wall of ventricle or rupture of chordae (4) Cardiac dysfunction (degree II or above) existed before Mi and was not effectively controlled; (5) Prior to the onset of the MI, there was a moderate to severe valvular heart disease (stenosis or insufficiency of the valve for any reason) and no effective treatment was available; (6) The patient had other organ dysfunction (such as liver and kidney dysfunction) prior to the onset of Mi and had not been effectively controlled; (7) The patient had a life expectancy of less than 1 year with tumor in any part of the body; (8) The patient had undergone invasive surgery in the past 1 month, or require surgery for any part other than the heart in the next six months; (9) Have a history of Endocarditis attack in the last 3 months; (10) Coagulopathy not effectively controlled.

Design outcomes

Primary

MeasureTime frame
all-cause death;

Secondary

MeasureTime frame
MACE;rehospital;heart function;

Countries

China

Contacts

Public ContactYuhao Liu

Fuwai Central China Cardiovascular Hospital

camsliu@163.com+86 13783692220

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026