Predictive Value of Risk Scores in Acute Coronary Syndrome | NCT03549481

Studies
Predictive Value of Risk Scores in Acute Coronary Syndrome

NCT03549481

Sponsor

shaimaa Mostafa

Status

Unknown status

Last Update Posted

Aug 23, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome
Left Ventricle Remodeling
Risk Scores

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

Aug 2018

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

Jul 9, 2018Actual

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

May 25, 2018

First Submission Date that Met QC Criteria

May 25, 2018

First Posted Date

Jun 8, 2018Actual

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

Aug 21, 2018

Last Update Posted Date

Aug 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

shaimaa Mostafa, assistant professor of cardiovascular medicicne, Benha UniversitySponsor-Investigator

Lead Sponsor

shaimaa MostafaOTHER

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

role of different risk scores in acute coronary syndrome to predict left ventricular remodeling

Detailed Description

patients with acute coronary syndrome (STEMI, NSTEMI, UA) will be included and different risk scores will be calculated for each patient.

after that in-hospital and short-term outcome beside left ventricular systolic and diastolic functions (at admission and 3m later) will be assessed to be correlated with different risk scores to determine which score system was able to predict left ventricular remodeling and what was the cut off value, sensitivity, and specificity of the score

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
left ventricular remodeling	end diastolic volume, end systolic volume, ejection fraction	3 months
in hospital and short term outcme	re-infarction, death, arrhythmia	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with acute coronary syndrome

Exclusion Criteria:

previous acute coronary syndrome previous PCI or CABG chronic renal disease decompensated liver disease patient refusal to participate patients dropped during follow up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adult patients of both gender with acute coronary syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shaimaa A Mostafa, MD	Contact	01229122843	0020	shaimaamustafa2011@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
shaimaa Mostafa	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D020257	Ventricular Remodeling

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided