Mechanical Complications of Acute Myocardial Infarction

Post-Infarction Heart Rupture Clinical Trial

— CAUTION  

Official title:

Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study (CAUTION Study 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848429
• Other study ID #: NL69173.068.19
• Status: Completed
• 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
• 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:

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Heart Septal Defects, Ventricular
• Infarction
• Myocardial Infarction
• Post-Infarction Heart Rupture
• Post-Infarction Mitral Papillary Muscle Rupture
• Post-Infarction Ventricular Septal Defect
• Rupture

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)

Arnaoutakis GJ, Zhao Y, George TJ, Sciortino CM, McCarthy PM, Conte JV. Surgical repair of ventricular septal defect after myocardial infarction: outcomes from the Society of Thoracic Surgeons National Database. Ann Thorac Surg. 2012 Aug;94(2):436-43; dis — View Citation

Chevalier P, Burri H, Fahrat F, Cucherat M, Jegaden O, Obadia JF, Kirkorian G, Touboul P. Perioperative outcome and long-term survival of surgery for acute post-infarction mitral regurgitation. Eur J Cardiothorac Surg. 2004 Aug;26(2):330-5. — View Citation

French JK, Hellkamp AS, Armstrong PW, Cohen E, Kleiman NS, O'Connor CM, Holmes DR, Hochman JS, Granger CB, Mahaffey KW. Mechanical complications after percutaneous coronary intervention in ST-elevation myocardial infarction (from APEX-AMI). Am J Cardiol. — View Citation

Haddadin S, Milano AD, Faggian G, Morjan M, Patelli F, Golia G, Franchi P, Mazzucco A. Surgical treatment of postinfarction left ventricular free wall rupture. J Card Surg. 2009 Nov-Dec;24(6):624-31. doi: 10.1111/j.1540-8191.2009.00896.x. — View Citation

Insam C, Paccaud F, Marques-Vidal P. Trends in hospital discharges, management and in-hospital mortality from acute myocardial infarction in Switzerland between 1998 and 2008. BMC Public Health. 2013 Mar 25;13:270. doi: 10.1186/1471-2458-13-270. — View Citation

Jennings SM, Bennett K, Lonergan M, Shelley E. Trends in hospitalisation for acute myocardial infarction in Ireland, 1997-2008. Heart. 2012 Sep;98(17):1285-9. doi: 10.1136/heartjnl-2012-301822. Epub 2012 Jul 16. — View Citation

Lang IM, Forman SA, Maggioni AP, Ruzyllo W, Renkin J, Vozzi C, Steg PG, Hernandez-Garcia JM, Zmudka K, Jimenez-Navarro M, Sopko G, Lamas GA, Hochman JS. Causes of death in early MI survivors with persistent infarct artery occlusion: results from the Occlu — View Citation

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, — View Citation

Rogers WJ, Frederick PD, Stoehr E, Canto JG, Ornato JP, Gibson CM, Pollack CV Jr, Gore JM, Chandra-Strobos N, Peterson ED, French WJ. Trends in presenting characteristics and hospital mortality among patients with ST elevation and non-ST elevation myocard — View Citation

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)