Post-Infarction Heart RuptureCAUTIONNCT03848429
Mechanical Complications of Acute Myocardial Infarction
An observational study of Post-Infarction Heart Rupture and Post-Infarction Ventricular Septal Defect, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Infarction Heart Rupture, Post-Infarction Ventricular Septal Defect, Post-Infarction Mitral Papillary Muscle Rupture
- What is being tested?
- Surgery for mechanical complications of acute myocardial infarction
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients ≥ 18 years old;
- Patients who received surgical treatment for mechanical complications of AMI from January 2001 to December 2018.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study (CAUTION Study 1)
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.
Read more
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.
Read the 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.
- Conditions
- Post-Infarction Heart Rupture, Post-Infarction Ventricular Septal Defect, Post-Infarction Mitral Papillary Muscle Rupture
- Being tested
- Surgery for mechanical complications of acute myocardial infarction
- Medical subject headings
- Heart Rupture, Post-Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for mechanical complications of acute myocardial infarctionProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital survival
To assess the in-hospital survival rate of patients underwent cardiac surgery for mechanical complications of AMI
Measured: 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.
Measured: 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.
Measured: Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks)
Secondary outcomes (2)
Long-term survival
To assess the long-term survival rate of patients underwent cardiac surgery for mechanical complications of AMI
Measured: Time interval from hospital discharge to follow-up (expected: up to 100 months)
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.
Measured: Time interval from hospital discharge to follow-up (expected: up to 100 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jun 2019
- Primary completion31 Jan 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Post-Infarction Heart RuptureStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848429
- Sponsor's protocol ID
- NL69173.068.19
- Acronym
- CAUTION
- Status last verified
- Aug 2022
- First submitted
- 12 Feb 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25520374Lang 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.
PubMed 20142183French 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.
PubMed 20102891Rogers 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.
PubMed 19032996Insam 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.
PubMed 23530470Jennings 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.
PubMed 22802000Arnaoutakis 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.
PubMed 22626761Chevalier 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.
PubMed 15296892Haddadin 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.
PubMed 20078707Massimi 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.
PubMed 40845148Massimi 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.
PubMed 34718501
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study (CAUTION Study 1)
- ClinicalTrials.gov ID
- NCT03848429
- Acronym / sponsor ID
- CAUTION / NL69173.068.19
- Conditions
- Post-Infarction Heart Rupture, Post-Infarction Ventricular Septal Defect, Post-Infarction Mitral Papillary Muscle Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years old;
- Patients who received surgical treatment for mechanical complications of AMI from January 2001 to December 2018.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for mechanical complications of acute myocardial infarctionSurgical 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 | Procedure or surgery | – |
Primary outcome
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
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.
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.
2 secondary outcomes
Long-term survival
Time frame: Time interval from hospital discharge to follow-up (expected: up to 100 months)
Post-operative quality of life
Time frame: Time interval from hospital discharge to follow-up (expected: up to 100 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Results publication: PubMed 25520374Mozaffarian 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.
- Results publication: PubMed 20142183Lang 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.
- Results publication: PubMed 20102891French 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.
- Results publication: PubMed 19032996Rogers 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.
- Results publication: PubMed 23530470Insam 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.
- Results publication: PubMed 22802000Jennings 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.
- Results publication: PubMed 22626761Arnaoutakis 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.
- Results publication: PubMed 15296892Chevalier 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.
- Results publication: PubMed 20078707Haddadin 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.
- Derived from this study: PubMed 40845148Massimi 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.
- Derived from this study: PubMed 34718501Massimi 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Infarction Heart Rupture and Post-Infarction Ventricular Septal Defect, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital survival (time frame: Time interval from cardiac surgery to hospital discharge (expected: up to 4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848429, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.