NCT03485742

Brief Summary

The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is

  1. 1.Cross sectional
  2. 2.Non interventional
  3. 3.One encounter per patient. No follow up. It addresses a major issue of primary prevention in Jordanians especially the young population, namely the issue of lipid lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of patients who sustained MI were not eligible to statins had they been evaluated before the heart attack. It is largely unknown if a larger percentage of Middle Eastern patients who sustain a heart attack would be eligible to receive lipid lowering agents.
  4. 4.The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

March 17, 2018

Last Update Submit

June 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Eligible patients for statin therapy

    The primary outcome is to calculate the percentage of enrolled patients who do meet the AHA/ACC Guidelines for receiving statins as a primary prevention measure.

    Within 24 hour of enrollment

Interventions

No intervention. Collection of data on statin eligibility in patients admitted with MI

Eligibility Criteria

Age30 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale, female
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 30 to 75 years admitted with MI (ST elevation and non ST elevation) who are not receiving statins prior to admission will be evaluated for potential eligibility had they been evaluated prior to admission with MI.

You may qualify if:

  • Adults admitted with MI, age 30 to 75
  • known lipid profile

You may not qualify if:

  • on statin before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Istishari Hospital

Amman, 11184, Jordan

Location

The University of Jordan

Amman, 11942, Jordan

Location

Jordan Hospital

Amman, Jordan

Location

Khalidi Hospital & Medical Center

Amman, Jordan

Location

King Abdullah University Hospital

Irbid, Jordan

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yasmine Obeidat, MS

    Hashemmeyyeh University School of Medicine, Zarka, Jordan

    STUDY DIRECTOR
  • Ayman J Hammoudeh, MD, FACC

    Istishari Hospital, Department of Cardiology, Amman, Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2018

First Posted

April 2, 2018

Study Start

April 22, 2019

Primary Completion

June 10, 2019

Study Completion

June 10, 2019

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

All IPD files will be available for all study researchers: clinical data, lipid profile data, 10 year risk score data, statin eligibility data.

Locations