The Time Delay Correlated With LV Functions and Heart Fai... | NCT05097755

Studies
The Time Delay Correlated With LV Functions and Heart Failure Incidence in STEMI?!

NCT05097755

Sponsor

mustafa Zayan Abdelsayed Mohamed

Status

Unknown status

Last Update Posted

Jan 25, 2023Actual

Enrollment

345Estimated

Phase

Not provided

Conditions

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

Jan 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

Mar 1, 2023Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Oct 17, 2021

First Submission Date that Met QC Criteria

Oct 17, 2021

First Posted Date

Oct 28, 2021Actual

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

Jan 21, 2023

Last Update Posted Date

Jan 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

mustafa Zayan Abdelsayed Mohamed, resident physician, Assiut UniversitySponsor-Investigator

Lead Sponsor

mustafa Zayan Abdelsayed MohamedOTHER

Collaborators

Not provided

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

To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI

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

345Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to what extent could the time be relevant to the incidence of Heart failure	is the time delay correlated with LV functions and heart failure incidence?!	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with anterior STEMI according to ESC guidelines 2017.
Subjects undergoing PPCI for the first time .
Non diabetic patients.

Exclusion Criteria:

• Patients with previous PCI.
- Patients with previous CABG.
- Patients with TIMI flow II or less .
- Cardiogenic shock.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patients will be subjected to:
Calculation of time from the first medical contact to time of primary PCI.
- Full history taking: including age, sex, history of HTN, Smoking, dyslipidemia, IHD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mustafa Z. Abdelsayed	Contact	+20 1067982167		mustafa.zaian54@gmail.com
Hatem A. Helmy	Contact	+20 100 521 2162		hatem19652007@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided