Cardiovascular Risk Categories and Attaining LDL-C Target... | NCT05745272

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

NCT05745272

Sponsor

Jordan Collaborating Cardiology Group

Status

Terminated

Last Update Posted

Jan 31, 2024Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Atherosclerotic Cardiovascular Risk
Low-density-lipoprotein (LDL) Cholesterol

Interventions

Not provided

Countries

Jordan

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No enough patients to be enrolled

Expanded Access Info

Start Date

Dec 11, 2023Actual

Primary Completion Date

Dec 15, 2023Actual

Completion Date

Dec 24, 2023Actual

First Submitted Date

Feb 16, 2023

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 27, 2023Actual

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

Jan 29, 2024

Last Update Posted Date

Jan 31, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Jordan Collaborating Cardiology GroupOTHER

Collaborators

Name	Class
The Cardiovascular Academy Group of the JCS	UNKNOWN
The Jordan Cardiac Society (JCS)	UNKNOWN
Istishari Hospital Department of Clinical Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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.

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

1,000Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
LDL-cholesterol blood level	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istishari Hospital		Amman		11184	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

CRF (CSR)

Types

Clinical Study Report (CSR)

Time Frame

April 2023 for 14 months

Access Criteria

Not provided

URL

Not provided