Mechanical Complications of Acute Myocardial Infarction

NCT03848429 | Completed

• 1 other identifier: NL69173.068.19
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Infarction Heart Rupture; Post-Infarction Ventricular Septal Defect; Post-Infarction Mitral Papillary Muscle Rupture

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (2)

• Long-term survival

  Time interval from hospital discharge to follow-up (expected: up to 100 months)

• Post-operative quality of life

  Time interval from hospital discharge to follow-up (expected: up to 100 months)

Interventions

Surgery for mechanical complications of acute myocardial infarction PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients ≥ 18 years old;
• Patients who received surgical treatment for mechanical complications of AMI from January 2001 to December 2018.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Matteucci Matteo

Maastricht, Netherlands

Location

Related Publications (11)

• Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres 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. No abstract available.

  PMID: 25520374 RESULT

• 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 Occluded Artery Trial (OAT). EuroIntervention. 2009 Nov;5(5):610-8. doi: 10.4244/eijv5i5a98.

  PMID: 20142183 RESULT

• 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. 2010 Jan 1;105(1):59-63. doi: 10.1016/j.amjcard.2009.08.653.

  PMID: 20102891 RESULT

• 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 myocardial infarction in the National Registry of Myocardial Infarction from 1990 to 2006. Am Heart J. 2008 Dec;156(6):1026-34. doi: 10.1016/j.ahj.2008.07.030. Epub 2008 Nov 1.

  PMID: 19032996 RESULT

• 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.

  PMID: 23530470 RESULT

• 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.

  PMID: 22802000 RESULT

• 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; discussion 443-4. doi: 10.1016/j.athoracsur.2012.04.020. Epub 2012 May 23.

  PMID: 22626761 RESULT

• 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. doi: 10.1016/j.ejcts.2004.04.027.

  PMID: 15296892 RESULT

• 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.

  PMID: 20078707 RESULT

• Massimi G, Matteucci M, De Bonis M, Kowalewski M, Formica F, Russo CF, Sponga S, Vendramin I, Colli A, Falcetta G, Trumello C, Carrozzini M, Fischlein T, Troise G, Dato GA, D'Alessandro S, Sardari Nia P, Lodo V, Villa E, Shah SH, Scrofani R, Binaco I, Kalisnik JM, Dell'Uomo M, Pettinari M, Thielmann M, Meyns B, Khouqeer FA, Fino C, Simon C, Musazzi A, Kowalowka A, Deja MA, Pisani A, Batko J, Borghetti V, Ronco D, Di Mauro M, Lorusso R. Repair Versus Replacement in Mitral Valve Papillary Muscle Rupture: A Multicenter Study. Eur J Cardiothorac Surg. 2025 Sep 2;67(9):ezaf284. doi: 10.1093/ejcts/ezaf284.

  PMID: 40845148 DERIVED

• Massimi G, Ronco D, De Bonis M, Kowalewski M, Formica F, Russo CF, Sponga S, Vendramin I, Falcetta G, Fischlein T, Troise G, Trumello C, Actis Dato G, Carrozzini M, Shah SH, Coco VL, Villa E, Scrofani R, Torchio F, Antona C, Kalisnik JM, D'Alessandro S, Pettinari M, Sardari Nia P, Lodo V, Colli A, Ruhparwar A, Thielmann M, Meyns B, Khouqeer FA, Fino C, Simon C, Kowalowka A, Deja MA, Beghi C, Matteucci M, Lorusso R. Surgical treatment for post-infarction papillary muscle rupture: a multicentre study. Eur J Cardiothorac Surg. 2022 Jan 24;61(2):469-476. doi: 10.1093/ejcts/ezab469.

  PMID: 34718501 DERIVED

MeSH Terms

Conditions

Heart Rupture, Post-Infarction

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Heart Rupture; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 20, 2019
• Study Start: June 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

NL (1)