Acute Myocardial Infarction in Native Versus Non-native Y... | NCT04427046

Studies
Acute Myocardial Infarction in Native Versus Non-native Young Population in Saudi Arabia

NCT04427046

Sponsor

Saud Al Babtain Cardiac Center

Status

Completed

Last Update Posted

Oct 26, 2022Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

Saudi Arabia

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 9, 2020Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Jun 9, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 11, 2020Actual

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

Oct 25, 2022

Last Update Posted Date

Oct 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A retrospective study collecting the data of young patients admitted with diagnosis of Acute Myocardial Infarction.

Detailed Description

A retrospective study investigating young adults aged <45 years for males and <55 years for females admitted at Saud Al Babtain Cardiac Center with diagnosis of Acute Myocardial Infarction, determining its risk factors for Coronary Artery Disease (CAD) related to cultural characteristics and common positive consanguinity of parents as well as the prevalent diabetes and smoking.

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

600Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of young adults hospitalized with primary diagnosis of Acute Myocadial Infarction.	Clinical Presentation and Outcome of Acute Myocardial Infarction in Native Versus Non-native Young Population in Saudi Arabia	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

<45 years old for male and <55 years old for female
patients admitted with diagnosis of Acute Myocardial Infarction

Exclusion Criteria:

<17 and >55 years old male and female
patients admitted with diagnosis other than Acute Myocardial Infarction.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Young adults, saudi or non-saudi, with Acute Myocardial Infarction.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ali Youssef, MD	Saud Al Babtain Cardiac Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saud Al Babtain Cardiac Center		Dammam		31463	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided