- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06546228
Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization
August 7, 2024 updated by: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
652
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Messina, Italy
- Azienda Ospedaliera Universitaria G. Martino
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized for acute coronary syndrome (ACS)
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Known coronary artery disease or previous ACS.
- PCI following CABG.
- Cardiogenic shock.
- Atrial fibrillation.
- Peripheral artery disease.
- Severe cardiac valve disease.
- Prosthetic aorta.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Acute Myocardial Infarction (AMI)
Time Frame: 7 years
|
Occurrence of AMI.
Unit of measure: Medical records, electrocardiogram (ECG), cardiac biomarkers
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: 7 years
|
LVEF before and after revascularization Measurement Tool: Echocardiogram Unit of Measure: Percentage (%) change in LVEF
|
7 years
|
|
Incidence of Cardiovascular Death
Time Frame: 7 years
|
Occurrence of cardiovascular death Measurement Tool: Medical records Unit of Measure: Number of cardiovascular deaths per patient-year
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
July 12, 2024
First Submitted That Met QC Criteria
August 7, 2024
First Posted (Actual)
August 9, 2024
Study Record Updates
Last Update Posted (Actual)
August 9, 2024
Last Update Submitted That Met QC Criteria
August 7, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Anonymous data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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