Clinical Characteristics and Prognosis of STEMI Patients... | NCT05679843

Studies
Clinical Characteristics and Prognosis of STEMI Patients Undergoing Primary Percutaneous Coronary Angioplasty and Angiographic Data

NCT05679843

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jun 7, 2023Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

STEMI - ST Elevation Myocardial Infarction

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2023Estimated

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Dec 24, 2022

First Submission Date that Met QC Criteria

Dec 24, 2022

First Posted Date

Jan 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2023

Last Update Posted Date

Jun 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42013226	Derived	Popovic B, Djaballah N, Tomic M, Fay R, Fraichot V, Eggenspieler F, Metzdorf PA, Varlot J, Camenzind E. Influence of the Residual Gensini Score on Prognosis of Patients With ST-Elevation Myocardial Infarction. Catheter Cardiovasc Interv. 2026 Apr 21. doi: 10.1002/ccd.70633. Online ahead of print.
38742522	Derived

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases