Clinical Characteristics and Prognosis of STEMI Patients Undergoing Primary Percutaneous Coronary Angioplasty and Angiographic Data (GensiniMI)

June 6, 2023 updated by: Batric POPOVIC, Central Hospital, Nancy, France

Characteristics and Prognosis of STEMI Patients Undergoing Primary PCI According to Coronary Occlusion Physiopathogeny and/or Atherosclerotic Burden

Gensini score (GS) provides valuable information on severity and prognosis of coronary artery disease (CAD). We aim to evaluate the relationship between the severity of CAD determined by the GS and short and long term of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with STEMI underwent primary PCI within 24 hours after first symptoms in our hospital

Description

Inclusion Criteria:

  • Patients with STEMI underwent primary PCI within 24 hours after first symptoms

Exclusion Criteria:

Patients with STEMI 24 hours after first symptoms Pregnant patient <18 years old

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite outcome including all cause death and re myocardial infarction
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
ST resolution on ECG after primary PCI
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

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 (Estimated)

June 7, 2023

Primary Completion (Estimated)

June 30, 2023

Study Completion (Estimated)

July 1, 2023

Study Registration Dates

First Submitted

December 24, 2022

First Submitted That Met QC Criteria

December 24, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CentralHNF number 2022PI183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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