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Mechanical Complications of Acute Myocardial Infarction (CAUTION)

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ClinicalTrials.gov Identifier: NCT03848429
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.


Condition or disease Intervention/treatment
Post-Infarction Heart Rupture Post-Infarction Ventricular Septal Defect Post-Infarction Mitral Papillary Muscle Rupture Procedure: Surgery for mechanical complications of acute myocardial infarction

Detailed Description:

Coronary artery disease (CAD) is a major cause of mortality and morbidity worldwide. In the United States cardiovascular disease is the leading cause of death in people older than 65 years. In the current era, a complete recovery after an acute myocardial infarction (AMI) has become the norm. Unfortunately, however, the mortality for some patients remains high. In particular, patients with cardiogenic shock after an AMI have less than a 50% chance of surviving their hospital stay.

Cardiogenic shock in AMI may result from ventricular dysfunction or it may result from mechanical complications requiring emergency surgical treatment; these include: papillary muscle rupture, ventricular free wall rupture and ventricular septal defect.

With the advent of percutaneous coronary intervention (PCI), there has been a significant drop in the incidence of post-infarction mechanical complications.The incidence of mechanical complications after acute ST elevation MI (STEMI) in the APEX-MI trial, where primary PCI was the reperfusion strategy, was 0.9%.

Although the incidence has decreased in the last decades, mortality in patients who develop these complications after AMI still remains very high. Mechanical complications must be carefully searched for in any patient with an acute coronary syndrome and signs of cardiogenic shock. The diagnosis, or even the suspicion, requires urgent surgical referral and in most cases necessitates emergency surgery.

The management of patients with postinfarction mechanical complications requires the consideration of several factors: (i) the extremely poor prognosis without surgical treatment; (ii) the higher mortality risk associated with emergency surgery; (iii) the potential rapid deterioration of initially stable patients.

Data from the Society of Thoracic Surgeons National Database demonstrated an average 43% in-hospital/30-day mortality for surgical treatment of ventricular septal defect. Reports on outcomes in large free wall rupture and papillary muscle rupture cohorts are scarce; based on available data, in-hospital mortality after surgery is around 20-25% for acute mitral regurgitation and 12-36% for ventricular free wall rupture.

In conclusion, 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 surgical 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-infarction mechanical complications.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study (CAUTION Study 1)
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack


Intervention Details:
  • 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


Primary Outcome Measures :
  1. In-hospital survival [ Time Frame: Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks) ]
    To assess the in-hospital survival rate of patients underwent cardiac surgery for mechanical complications of AMI

  2. Left ventricular free-wall (LVFW) re-rupture [ Time Frame: Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks) ]
    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.

  3. Ventricular septal defect (VSD) recurrence [ Time Frame: Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks) ]
    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.


Secondary Outcome Measures :
  1. Long-term survival [ Time Frame: Time interval from hospital discharge to follow-up (expected: up to 100 months) ]
    To assess the long-term survival rate of patients underwent cardiac surgery for mechanical complications of AMI

  2. Post-operative quality of life [ Time Frame: Time interval from hospital discharge to follow-up (expected: up to 100 months) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients (≥ 18 years) that required cardiac surgery for mechanical complications of AMI in the participating center from January 2001 to December 2018. Expected population number: 300 patients.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848429


Contacts
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Contact: Matteo Matteucci, MD +39 3493556001 matteomatteucci87@gmail.com
Contact: Federica Jiritano, MD +39 3316932936 fede.j@hotmail.it

Locations
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Netherlands
Matteucci Matteo Recruiting
Maastricht, Netherlands
Contact: Matteo Matteucci, MD    +393493556001    matteomatteucci87@gmail.com   
Contact: Federica Jiritano, MD    +393316932936    fede.j@hotmail.it   
Sub-Investigator: Matteo Matteucci, MD         
Principal Investigator: Roberto Lorusso, MD, PhD         
Sub-Investigator: Federica Jiritano, MD         
Sub-Investigator: Dario Fina, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Publications of Results:
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03848429    
Other Study ID Numbers: NL69173.068.19
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Septal Defects, Ventricular
Heart Rupture
Heart Rupture, Post-Infarction
Infarction
Rupture
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Wounds and Injuries
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities