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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03848429
Other study ID # NL69173.068.19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 31, 2020

Study information

Verified date August 2022
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery for mechanical complications of acute myocardial infarction
Surgical treatment of post-AMI left ventricular free-wall rupture: sutured and sutureless repair. Surgical treatment of post-AMI ventricular septal defect: infarctectomy and infarct exclusion repair. Surgical treatment of post-AMI papillary muscle rupture: mitral valve repair and replacement

Locations

Country Name City State
Netherlands Matteucci Matteo Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

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Outcome

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)
See also
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