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

January 29, 2024 updated by: Jordan Collaborating Cardiology Group
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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11184
        • Istishari Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Ambulatory care patients and in-hospital patients with any medical illness of coming for routine check ups.Age 18-55 both sexes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk level of ASCVD
Time Frame: 12 MONTHS
Categorizing the patients' level of ASCVD risk by the clinical background of CVD, DM, other risk factors and 10% year risk
12 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-cholesterol blood level
Time Frame: 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,
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan Collaborating Cardiology Group

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 24, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CVA-G/JCS-1/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CRF (CSR)

IPD Sharing Time Frame

April 2023 for 14 months

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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