StatinEPIC: Statin Eligibility Prior to Myocardial InfarCtion

Sponsor
Jordan Collaborating Cardiology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT03485742
Collaborator
(none)
740
5
1.6
148
91.9

Study Details

Study Description

Brief Summary

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

  1. Cross sectional

  2. Non interventional

  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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Statins, when use as primary cardiovascular prevention strategy, have been shown to lower future acute cardiovascular events, especially myocardial infarction. However the use of statins in this context (i.e., primary prevention) is governed by guidelines that limit the use of statins to four high risk populations: (1) hose with known cardiovascular disease, (2) those with low-density lipoprotein cholesterol (LDL-C) levels 190 mg/dl or above, (3) diabetics with LDL-C levels 70-189 mg/dl, and (4) those with an estimated 10-year atherosclerotic cardiovascular disease risk score of 7.5% or more.

Unfortunately, some individuals are still at risk of sustaining MI despite the fact that they do not fit into one of these four high risk groups eligible for statins.

StainEPIC will enroll consecutive patients admitted with MI who are not on statins to examine their eligibility for these medications based on the AHA/ACC guidelines.

Study Design

Study Type:
Observational
Actual Enrollment :
740 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Statin Eligibility Prior to Myocardial InfarCtion in Jordanians
Actual Study Start Date :
Apr 22, 2019
Actual Primary Completion Date :
Jun 10, 2019
Actual Study Completion Date :
Jun 10, 2019

Outcome Measures

Primary Outcome Measures

  1. Eligible patients for statin therapy [Within 24 hour of enrollment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Adults admitted with MI, age 30 to 75

  • known lipid profile

Exclusion Criteria:
  • on statin before enrollment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istishari Hospital Amman Jordan 11184
2 The University of Jordan Amman Jordan 11942
3 Jordan Hospital Amman Jordan
4 Khalidi Hospital & Medical Center Amman Jordan
5 King Abdullah University Hospital Irbid Jordan

Sponsors and Collaborators

  • Jordan Collaborating Cardiology Group

Investigators

  • Study Director: Yasmine Obeidat, MS, Hashemmeyyeh University School of Medicine, Zarka, Jordan
  • Principal Investigator: Ayman J Hammoudeh, MD, FACC, Istishari Hospital, Department of Cardiology, Amman, Jordan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier:
NCT03485742
Other Study ID Numbers:
  • JCCStatinEpic2018
First Posted:
Apr 2, 2018
Last Update Posted:
Jun 26, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2019