Myocardial Infarction (MI)NCT06799780
Study on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing
An observational study of Myocardial Infarction (MI) and Heart Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in 2 countries.
Trial summary
The main objective of the study is to identify the optimal surgical timing for the treatment of intraventricular defects after acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI), Heart Disease
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Feb 2024to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients undergoing surgical repair of post-AMI ventricular septal defect between January 1, 2001 and December 31, 2021.
Who may be able to join
- Patients over eighteen years of age
- Patients with post-myocardial infarction ventricular septal defect treated surgically
- Patients who have signed the informed consent
Who cannot join
- Patients with post-infarction ventricular septal defect treated with medical/conservative therapy
- Patients with ventricular septal defects not due to acute myocardial infarction
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Luca Di Marco, MD, +390512149044, luca.dimarco@aosp.bo.it
Luca Di Marco, MD
- Recruiting
Ospedale Santa Maria della Misericordia Udine
Udine, Udine, 33100
Sandro Sponga, MD, sandro_sponga@yahoo.com
Sandro Sponga, MD
- Recruiting
Ospedale di Circolo e Fondazione Macchi Varese
Varese, Varese, 21010
Matteo Matteucci, MD, matteomatteucci87@gmail.com
Matteo Matteucci, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic Barcellona
Barcelona, Barcellona, 08024
Alessandro Affronti, MD, affronti@clinic.cat
Alessandro Affronti, MD
About this study
Official title: Multicenter Study on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing
The main objective of the study is to identify the optimal surgical timing for the treatment of intraventricular defects after acute myocardial infarction.
Read the detailed description
Identify the optimal timing for the treatment of post-infarction ventricular defect, considering the time interval between the clinical-instrumental diagnosis and the surgical intervention.
- Conditions
- Myocardial Infarction (MI), Heart Disease
- Medical subject headings
- Myocardial Infarction, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the optimal timing for the surgical intervention.
The optimal timing considering the time interval between the clinical-instrumental diagnosis and the surgical intervention
Measured: Possible timing for surgery can be: onset of the infarction episode, hospital admission, before seven days from the acute myocardial infarction or after seven days from the acute myocardial infarction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start12 Feb 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Di Marco, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799780
- Sponsor's protocol ID
- DIV post-IMA
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing
- ClinicalTrials.gov ID
- NCT06799780
- Acronym / sponsor ID
- DIV post-IMA
- Conditions
- Myocardial Infarction (MI), Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Jan 2025 (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 main objective of the study is to identify the optimal surgical timing for the treatment of intraventricular defects after acute myocardial infarction.
Detailed description
Identify the optimal timing for the treatment of post-infarction ventricular defect, considering the time interval between the clinical-instrumental diagnosis and the surgical intervention.
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
- Adult patients undergoing surgical repair of post-AMI ventricular septal defect between January 1, 2001 and December 31, 2021.
Key inclusion criteria (3 listed)
- Patients over eighteen years of age
- Patients with post-myocardial infarction ventricular septal defect treated surgically
- Patients who have signed the informed consent
Key exclusion criteria (2 listed)
- Patients with post-infarction ventricular septal defect treated with medical/conservative therapy
- Patients with ventricular septal defects not due to 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.
Primary outcome
Identify the optimal timing for the surgical intervention.
Time frame: Possible timing for surgery can be: onset of the infarction episode, hospital admission, before seven days from the acute myocardial infarction or after seven days from the acute myocardial infarction.
The optimal timing considering the time interval between the clinical-instrumental diagnosis and the surgical intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Luca Di Marco, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction (MI) and Heart Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in 2 countries.
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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Di Marco, MD (0512149044 ext. +39, luca.dimarco@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the optimal timing for the surgical intervention. (time frame: Possible timing for surgery can be: onset of the infarction episode, hospital admission, before seven days from the acute myocardial infarction or after seven days from the acute myocardial infarction.). 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 29 Jan 2025.