Ventricular Septal RuptureCautionCov19NCT04813692
Mechanical Complications of Acute Myocardial Infarction During COVID-19 Pandemics
An observational study of Ventricular Septal Rupture and Papillary Muscle Rupture, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The ongoing COVID-19 pandemics has put an overwhelming pressure on the healthcare systems of many European countries. Such a situation has potentially led to delayed and impaired access to appropriate treatment for patients affected by other severe, non-COVID-19-related conditions, including cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Septal Rupture, Papillary Muscle Rupture, Free Wall Rupture, Heart
- What is being tested?
- Surgical repair, Percutaneous treatment and Mitral valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 31 Jul 2022
- 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 adult patients who were diagnosed with mechanical complications of acute myocardial infarction, between March 2018 to February 2021, independent of the treatment offered.
Who may be able to join
- patients ≥ 18 years old;
- recent diagnosis of acute myocardial infarction;
- presence of ventricular free-wall rupture and/or ventricular septal rupture and/or papillary muscle rupture.
Who cannot join
- patients < 18 years old;
- ventricular free-wall rupture or ventricular septal rupture or papillary muscle rupture not related with acute myocardial infarction.
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 During COVID-19 Pandemics (CautionCov19)
The ongoing COVID-19 pandemics has put an overwhelming pressure on the healthcare systems of many European countries. Such a situation has potentially led to delayed and impaired access to appropriate treatment for patients affected by other severe, non-COVID-19-related conditions, including cardiovascular diseases. This resulted in a reported lower admission, but higher mortality rate for AMI patients.
Such a situation might be explained by many factors, including unavailability of early reperfusion therapy and late hospital presentation of AMI patients due to a general anxiety related to the COVID-19 contagious risk of the hospital environment. As a matter of fact, during this year of pandemics, several case reports suggested a new, significant surge of post-AMI mechanical complications, sometimes describing patients admitted in too severe conditions to consider surgical repair a viable option, and therefore inevitably undergone an unfavorable outcome.
Therefore, we decided to involve the large network of European centers already participating to the "Caution Study 1", in order to study the impact of COVID-19 pandemics on the outcomes, incidence and treatments of post-AMI mechanical complications.
Read the detailed description
Mechanical complications must be carefully searched for in any patient with an acute coronary syndrome and signs of cardiogenic shock, as prompt diagnosis and immediate surgery often represent the only effective treatment for such ominous conditions.
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 rupture. Data from the same registry on papillary muscle rupture showed a 30-day mortality of 20%. Matteucci et al. recently reported a 36.4% mortality rate for free wall rupture from the large CAUTION multicenter study.
Given the low incidence of these post-AMI mechanical complications, evidence-based therapeutic strategies remain controversial, and little is known on the early clinical results and late follow-up, with most information derived from small single-center experiences or national registries.
Therefore, we started the "Mechanical complications of acute myocardial infarction: an international multicenter cohort study" - (Caution Study 1), a retrospective, international multicenter clinical trial aimed at evaluating the survival, postoperative outcome and quality of life of patients undergone cardiac surgery for post-infarction mechanical complications starting from 2001.
The ongoing COVID-19 pandemics, however, has put an overwhelming pressure on the healthcare systems of many European countries. Such a situation has potentially led to delayed and impaired access to appropriate treatment for patients affected by other severe, non-COVID-19-related conditions, including cardiovascular diseases. This resulted in a reported lower admission, but higher mortality rate for AMI patients.This situation might be explained by many factors, including unavailability of early reperfusion therapy and late hospital presentation of AMI patients due to a general anxiety related to the COVID-19 contagious risk of the hospital environment. As a matter of fact, during this year of pandemics, several case reports suggested a new, significant surge of post-AMI mechanical complications, sometimes describing patients admitted in too severe conditions to consider surgical repair a viable option, and therefore inevitably undergone an unfavorable outcome.
Therefore, we decided to involve the large network of European centers already participating to the "Caution Study 1", in order to study the impact of COVID-19 pandemics on the outcomes, incidence and treatments of post-AMI mechanical complications.
"Mechanical complications of acute myocardial infarction: an international multicenter cohort study during COVID-19 pandemics" is a retrospective, international multicenter clinical trial aimed at evaluating the trend of incidence, types of treatment and survival of patients admitted to hospital with a diagnosis of post-infarction mechanical complications.
- Being tested
- Surgical repair, Percutaneous treatment, Mitral valve surgery
- Medical subject headings
- Ventricular Septal Rupture, Heart Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repairProcedure or surgery
Surgical repair of post-infarction LVFWR or VSR
Percutaneous treatmentProcedure or surgery
Percutaneous closure of post-infarction VSR (or treatment for LVFWR)
Mitral valve surgeryProcedure or surgery
Mitral valve repair or replacement for post-infarction PMR
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 admitted with a diagnosis of post-AMI mechanical complications and underwent surgical or percutaneous treatment
Measured: interval from intervention (surgical or percutaneous) to hospital discharge (expected: up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Sep 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal 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
- 130 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
- NCT04813692
- Sponsor's protocol ID
- IT-VA:85/2021
- Acronym
- CautionCov19
- Status last verified
- Jun 2023
- First submitted
- 23 Mar 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. 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 During COVID-19 Pandemics (CautionCov19)
- ClinicalTrials.gov ID
- NCT04813692
- Acronym / sponsor ID
- CautionCov19 / IT-VA:85/2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 24 Mar 2021 (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.
The ongoing COVID-19 pandemics has put an overwhelming pressure on the healthcare systems of many European countries. Such a situation has potentially led to delayed and impaired access to appropriate treatment for patients affected by other severe, non-COVID-19-related conditions, including cardiovascular diseases. This resulted in a reported lower admission, but higher mortality rate for AMI patients.
Such a situation might be explained by many factors, including unavailability of early reperfusion therapy and late hospital presentation of AMI patients due to a general anxiety related to the COVID-19 contagious risk of the hospital environment. As a matter of fact, during this year of pandemics, several case reports suggested a new, significant surge of post-AMI mechanical complications, sometimes describing patients admitted in too severe conditions to consider surgical repair a viable option, and therefore inevitably undergone an unfavorable outcome.
Therefore, we decided to involve the large network of European centers already participating to the "Caution Study 1", in order to study the impact of COVID-19 pandemics on the outcomes, incidence and treatments of post-AMI mechanical complications.
Detailed description
Mechanical complications must be carefully searched for in any patient with an acute coronary syndrome and signs of cardiogenic shock, as prompt diagnosis and immediate surgery often represent the only effective treatment for such ominous conditions.
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 rupture. Data from the same registry on papillary muscle rupture showed a 30-day mortality of 20%. Matteucci et al. recently reported a 36.4% mortality rate for free wall rupture from the large CAUTION multicenter study.
Given the low incidence of these post-AMI mechanical complications, evidence-based therapeutic strategies remain controversial, and little is known on the early clinical results and late follow-up, with most information derived from small single-center experiences or national registries.
Therefore, we started the "Mechanical complications of acute myocardial infarction: an international multicenter cohort study" - (Caution Study 1), a retrospective, international multicenter clinical trial aimed at evaluating the survival, postoperative outcome and quality of life of patients undergone cardiac surgery for post-infarction mechanical complications starting from 2001.
The ongoing COVID-19 pandemics, however, has put an overwhelming pressure on the healthcare systems of many European countries. Such a situation has potentially led to delayed and impaired access to appropriate treatment for patients affected by other severe, non-COVID-19-related conditions, including cardiovascular diseases. This resulted in a reported lower admission, but higher mortality rate for AMI patients.This situation might be explained by many factors, including unavailability of early reperfusion therapy and late hospital presentation of AMI patients due to a general anxiety related to the COVID-19 contagious risk of the hospital environment. As a matter of fact, during this year of pandemics, several case reports suggested a new, significant surge of post-AMI mechanical complications, sometimes describing patients admitted in too severe conditions to consider surgical repair a viable option, and therefore inevitably undergone an unfavorable outcome.
Therefore, we decided to involve the large network of European centers already participating to the "Caution Study 1", in order to study the impact of COVID-19 pandemics on the outcomes, incidence and treatments of post-AMI mechanical complications.
"Mechanical complications of acute myocardial infarction: an international multicenter cohort study during COVID-19 pandemics" is a retrospective, international multicenter clinical trial aimed at evaluating the trend of incidence, types of treatment and survival of patients admitted to hospital with a diagnosis of 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 adult patients who were diagnosed with mechanical complications of acute myocardial infarction, between March 2018 to February 2021, independent of the treatment offered.
Key inclusion criteria (3 listed)
- patients ≥ 18 years old;
- recent diagnosis of acute myocardial infarction;
- presence of ventricular free-wall rupture and/or ventricular septal rupture and/or papillary muscle rupture.
Key exclusion criteria (2 listed)
- patients < 18 years old;
- ventricular free-wall rupture or ventricular septal rupture or papillary muscle rupture not related with acute myocardial infarction.
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 |
|---|---|---|
| Surgical repairSurgical repair of post-infarction LVFWR or VSR | Procedure or surgery | – |
| Percutaneous treatmentPercutaneous closure of post-infarction VSR (or treatment for LVFWR) | Procedure or surgery | – |
| Mitral valve surgeryMitral valve repair or replacement for post-infarction PMR | Procedure or surgery | – |
Primary outcome
In-hospital survival
Time frame: interval from intervention (surgical or percutaneous) to hospital discharge (expected: up to 4 weeks)
To assess the in-hospital survival rate of patients admitted with a diagnosis of post-AMI mechanical complications and underwent surgical or percutaneous treatment
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 12 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Ventricular Septal Rupture
RecruitingObservational study
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
Ventricular Septal Defect, Papillary Muscle Rupture
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 Ventricular Septal Rupture and Papillary Muscle Rupture, 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 3 inclusion and 2 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 12 Jun 2023. 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: interval from intervention (surgical or percutaneous) to hospital discharge (expected: up to 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2023.