Assiut University Registry for ACS Patients During COVID-... | NCT04691609

Studies
Assiut University Registry for ACS Patients During COVID-19 Pandemic

NCT04691609

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 31, 2020Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

ACS-COVID-19-Assiut

Interventions

Not provided

Countries

Egypt

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Sep 2023Estimated

First Submitted Date

Sep 21, 2020

First Submission Date that Met QC Criteria

Dec 29, 2020

First Posted Date

Dec 31, 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

Dec 29, 2020

Last Update Posted Date

Dec 31, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samah ObiedAllah Fouad, Principal investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic

Detailed Description

In the face of the quickly evolving coronavirus disease 2019 (COVID-19) pandemic, many health-care systems around the globe have modified their routine management of patients presenting with acute cardiovascular emergencies including patients with ACS.A unifying theme in the new management strategies is the adoption of new restrictive measures to meet the challenges of increased risk of infection of health-care workers; limited numbers of beds, shortage of personal protective equipment (PPE), inadequate number of protected catheterization rooms; and the clinical overlap between ACS and COVID-19 infection in some of patients.

In developing countries, with an already strained health system due to economic problems, the situation is more challenging and needs the formulation of efficient protocols that can accommodate several medical and socioeconomic challenges.

Egypt, with an estimated population of 100 million, is facing exceptional challenges during the COVID-19 crisis. Because large scale use of polymerase chain reaction (PCR) test for SARS-CoV-2 in a large population is a problem, the prevalence of COVID-19 infection in Egypt is unknown. Furthermore, the supply of PPE falls far short of demands with lack of professionally protected cardiac catheterization rooms. With progression of the pandemic in such a large population, care of COVID-19 patients is expected to rapidly overwhelm the supplies, beds, and staff available in Egyptian hospitals.

The Cardiology Department in Assiut university hospital has revised the management protocols for ACS patients and implemented new management protocols both for patients with ST-segment elevation myocardial infarction (STEMI) and Non-ST-segment elevation acute coronary syndromes (NSTE-ACS).

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

2,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main Number, distribution and oucome of all ACS patients coming to Assiut heart hospital	Number, distribution and outcome of all ACS patients coming to Assiut heart hospital(as age, gender, risk factors of coronary artery diseases and their effect on incidence and progress of ACS )	about 1 year

Secondary Outcomes

Measure	Description	Time Frame
To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic	To evaluate clinical symptoms and signs of COVID -19 and acute coronary syndrome(Type of ACS, type of intervention or treatment for each case,complications if peresent, COVID - 19 status and if it affects ACS patient or not and follow up after 3 months and 1 year)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting with symptoms or ECG indicative of acute coronary syndrome admitted to Assiut heart hospital

Exclusion Criteria:

The only exclusion criteria is refusal of the patient to participate in the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

ACS patients admitted to Assiut university heart hospital either male or female, young or old, COVID-19 confirmed, suspected or even excluded.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samah obiedallah Fouad, resident	Contact	01069612646		samahfouad847@yahoo.com
Amr Ahmed yousef, professor	Contact	01006554042		amryoussef111@yahoo.com

Overall Officials

Name	Affiliation	Role
Ayman Khairy Hassan, Lecturer	aymankhairy11@gmail.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samah ObiedAllah Fouad	Recruiting	Asyut	Resident		Egypt