Acute Myocardial InfarctionNCT06546228
Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization
An observational study of Acute Myocardial Infarction and Revascularization, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial summary
Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction, Revascularization
- How many people
- 652 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2021to 31 Dec 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients hospitalized for acute coronary syndrome (ACS)
Who may be able to join
- Patients met the criteria for Acute Coronary Syndrome (ACS) as defined by the Joint European Society of Cardiology/American College of Cardiology Committee.
- Patients underwent immediate coronary revascularization (primary PCI) for ST-Elevation Myocardial Infarction (STEMI).
- Patients underwent coronary revascularization (early PCI) within 24 hours for Non-ST-Elevation Myocardial Infarction (NSTEMI).
- Patients underwent diagnostic coronary angiography following coronary artery bypass graft surgery (CABG).
Who cannot join
- Known coronary artery disease or previous ACS.
- PCI following CABG.
- Cardiogenic shock.
- Atrial fibrillation.
- Peripheral artery disease.
- Severe cardiac valve disease.
- Prosthetic aorta.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization: a Machine Learning Analysis After a 7 Years Follow-up
Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. The purpose of this research was to investigate the factors allowing to acute coronary syndrome, related to the metabolic status, to help guide each patient toward early preventing behaviors.
- Conditions
- Acute Myocardial Infarction, Revascularization
- Being tested
- No intervention. Only observational.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Only observational.Other
Only collection of data or parameters already required by the medical examination programmed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Myocardial Infarction (AMI)
Occurrence of AMI. Unit of measure: Medical records, electrocardiogram (ECG), cardiac biomarkers
Measured: 7 years
Secondary outcomes (2)
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF before and after revascularization Measurement Tool: Echocardiogram Unit of Measure: Percentage (%) change in LVEF
Measured: 7 years
Incidence of Cardiovascular Death
Occurrence of cardiovascular death Measurement Tool: Medical records Unit of Measure: Number of cardiovascular deaths per patient-year
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546228
- Sponsor's protocol ID
- 01-21
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous data
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization: a Machine Learning Analysis After a 7 Years Follow-up
- ClinicalTrials.gov ID
- NCT06546228
- Acronym / sponsor ID
- 01-21
- Conditions
- Acute Myocardial Infarction, Revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Aug 2024 (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.
Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. The purpose of this research was to investigate the factors allowing to acute coronary syndrome, related to the metabolic status, to help guide each patient toward early preventing behaviors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized for acute coronary syndrome (ACS)
Key inclusion criteria (4 listed)
- Patients met the criteria for Acute Coronary Syndrome (ACS) as defined by the Joint European Society of Cardiology/American College of Cardiology Committee.
- Patients underwent immediate coronary revascularization (primary PCI) for ST-Elevation Myocardial Infarction (STEMI).
- Patients underwent coronary revascularization (early PCI) within 24 hours for Non-ST-Elevation Myocardial Infarction (NSTEMI).
- Patients underwent diagnostic coronary angiography following coronary artery bypass graft surgery (CABG).
Key exclusion criteria (7 listed)
- Known coronary artery disease or previous ACS.
- PCI following CABG.
- Cardiogenic shock.
- Atrial fibrillation.
- Peripheral artery disease.
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 |
|---|---|---|
| No intervention. Only observational.Only collection of data or parameters already required by the medical examination programmed. | Other | – |
Primary outcome
Incidence of Acute Myocardial Infarction (AMI)
Time frame: 7 years
Occurrence of AMI. Unit of measure: Medical records, electrocardiogram (ECG), cardiac biomarkers
2 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: 7 years
Incidence of Cardiovascular Death
Time frame: 7 years
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 9 Aug 2024.
- Individual participant dataSharing planned: No. Anonymous data
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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. 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 Acute Myocardial Infarction and Revascularization, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
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 4 inclusion and 7 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 9 Aug 2024. 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 Italy. 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?
Incidence of Acute Myocardial Infarction (AMI) (time frame: 7 years). 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 9 Aug 2024.