Clincosm LogoSign in Get a demo

CREATE: Cardiovascular Risk Categories and Attaining LDL-C Targets in Middle Eastern Adults Aged 30-55 Years of Age

Sponsor
Jordan Collaborating Cardiology Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05745272
Collaborator
The Cardiovascular Academy Group of the JCS (Other), The Jordan Cardiac Society (JCS) (Other), Istishari Hospital Department of Clinical Research (Other)
1,000
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Individuals evaluated for primary and secondary cardiovascular prevention have different levels of cardiovascular risk These levels of risk are the main determinants of the low-density lipoprotein cholesterol (LDL-C) target blood levels that need to be attained.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Individuals evaluated for primary and secondary cardiovascular prevention fall into different levels of cardiovascular risk according to their clinical profile of having atherosclerotic cardiovascular disease (ASCVD), risk factors, and their SCORE. These levels of risk are the main determinants of the low-density lipoprotein cholesterol (LDL-C) target blood levels that need to be attained using LDL-C-lowering agents (LLA).

    Contemporary studies that evaluated levels of cardiovascular risk and LDL-C goal attainment in the Middle East are scarce. A prior study (CEPHEUS LEVANT) in the Middle East demonstrated that about 1 in 4 high-risk patients reach LDL-C goals.

    The current study aims at studying cardiovascular risk categories according to the 2019 ESC/EAS and 2018 ACC/AHA Guidelines, and the attainment of LDL-C treatment goals in consecutive individuals aged 18-55 years who are evaluated in tertiary care centers as inpatients or in ambulatory care settings. The above age bracket was chosen because these are the individuals most prone to acute cardiovascular events with a high prevalence of diabetes mellitus and cigarette smoking.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cardiovascular Risk Categories and Attaining LDL-C Targets in Middle Eastern Adults Aged 30-55 Years of Age
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Risk level of ASCVD [12 MONTHS]

      Categorizing the patients' level of ASCVD risk by the clinical background of CVD, DM, other risk factors and 10% year risk

    Secondary Outcome Measures

    1. LDL-cholesterol blood level [12 months]

      Calculating the LDL-C blood level in each patient according to the ASCVD risk category, and whether this level was attained by therapy,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Age 18-55 y

    • Individuals can give a history of the presence or absence of ASCVD and its risk factors

    Exclusion Criteria:

    • Age below 18 or older than 55

    • Refusal of inability to give history on ASCVD and its risk factors

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jordan Collaborating Cardiology Group
    • The Cardiovascular Academy Group of the JCS
    • The Jordan Cardiac Society (JCS)
    • Istishari Hospital Department of Clinical Research

    Investigators

    • Study Chair: Imad A. Alhaddad, MD FACC, Department of Cardiology, Jordan Hospital, Amman, Jordan
    • Study Director: Ramzi Tabbalat, Cardiology Department, Abdali Hospital
    • Principal Investigator: Ayman Hammoudeh, MD FACC, Department of Clinical Research, Istishari Hospital, Aman, Jordan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jordan Collaborating Cardiology Group
    ClinicalTrials.gov Identifier:
    NCT05745272
    Other Study ID Numbers:
    • CVA-G/JCS-1/2023
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jordan Collaborating Cardiology Group
    Low-density lipoprotein cholesterol (LDL-C)
    LDL-C targets
    ASCVD risk levels
    Middle East population

    Study Results

    No Results Posted as of Feb 27, 2023