Post-Infarction Heart Rupture Clinical Trial
— CAUTIONOfficial title:
Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study (CAUTION Study 1)
Verified date | August 2022 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Although the incidence of post-AMI mechanical complications has decreased in the last decades, mortality in patients who develop these complications after AMI still remains very high. Because of the rarity of these post-AMI mechanical complications, the optimal evidence-based therapeutic strategies remain controversial, and little is know on the early clinical results and late follow-up. Owing to the paucity and limitation of available data, investigations and analysis are required to help clinicians make an early diagnosis of these devastating complications, and offer to patients the appropriate treatment. "Mechanical complications of acute myocardial infarction: an international multicenter cohort study" (Caution Study 1) is a retrospective, international multicenter clinical trial aimed at evaluating the survival, postoperative outcome and quality of life of patients underwent cardiac surgery for post-AMI mechanical complications.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients = 18 years old; - Patients who received surgical treatment for mechanical complications of AMI from January 2001 to December 2018. Exclusion Criteria: - Patients who underwent medical/conservative management for post-AMI mechanical complications or cardiac surgery procedures (for example: left ventricular free wall rupture repair) not related with post-AMI complications (for example: traumatic ventricular wall rupture). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Matteucci Matteo | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-hospital survival | To assess the in-hospital survival rate of patients underwent cardiac surgery for mechanical complications of AMI | Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks) | |
Primary | Left ventricular free-wall (LVFW) re-rupture | To assess the LVFWR re-rupture rate of patients underwent post-infarction left ventricular free-wall rupture repair. The presence of LVFW re-rupture will be assessed by echocardiography, or intra-operatively during reoperation. | Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks) | |
Primary | Ventricular septal defect (VSD) recurrence | To assess the VSD recurrence rate of patients underwent post-infarction ventricular septal defect repair. The presence of VSD recurrence will be assessed by echocardiography. | Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks) | |
Secondary | Long-term survival | To assess the long-term survival rate of patients underwent cardiac surgery for mechanical complications of AMI | Time interval from hospital discharge to follow-up (expected: up to 100 months) | |
Secondary | Post-operative quality of life | To assess the quality of life at follow-up of patients underwent cardiac surgery for mechanical complications of AMI. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems: Level 1: indicating no problem; Level 2: indicating slight problems; Level 3: indicating moderate problems; Level 4: indicating severe problems; Level 5: indicating extreme problems. Higher scores indicate higher levels of health. An unique health state is defined by combining 1 level from each of the 5 dimensions. A total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. | Time interval from hospital discharge to follow-up (expected: up to 100 months) |
Status | Clinical Trial | Phase | |
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Recruiting |
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