Atherosclerotic Cardiovascular RiskCREATENCT05745272
Cardiovascular Risk Categories and Attaining LDL-C Targets in Middle Eastern Adults Aged 30-55 Years of Age
An observational study of Atherosclerotic Cardiovascular Risk and Low-density-lipoprotein (LDL) Cholesterol, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Risk, Low-density-lipoprotein (LDL) Cholesterol
- How many people
- 1,000 participants
- Where
- 1 siteJordan
- Study dates
- 11 Dec 2023to 24 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- 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.
Who may be able to join
- Age 18-55 y
- Individuals can give a history of the presence or absence of ASCVD and its risk factors
Who cannot join
- Age below 18 or older than 55
- Refusal of inability to give history on ASCVD and its risk factors
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Low-density lipoprotein cholesterol (LDL-C), LDL-C targets, ASCVD risk levels, Middle East population
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 MONTHS
Secondary outcomes (1)
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,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start11 Dec 2023
- Primary completion15 Dec 2023
- Study completion24 Dec 2023
Why it stopped: No enough patients to be enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Cardiovascular Academy Group of the JCS, The Jordan Cardiac Society (JCS), Istishari Hospital Department of Clinical Research
- Responsible party
- Sponsor
- Investigators
- Imad A. Alhaddad, MD FACC, Study chair, Department of Cardiology, Jordan Hospital, Amman, JordanRamzi Tabbalat, Study director, Cardiology Department, Abdali HospitalAyman Hammoudeh, MD FACC, Principal investigator, Department of Clinical Research, Istishari Hospital, Aman, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745272
- Sponsor's protocol ID
- CVA-G/JCS-1/2023
- Acronym
- CREATE
- Status last verified
- Jan 2024
- First submitted
- 16 Feb 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CRF (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Categories and Attaining LDL-C Targets in Middle Eastern Adults Aged 30-55 Years of Age
- ClinicalTrials.gov ID
- NCT05745272
- Acronym / sponsor ID
- CREATE / CVA-G/JCS-1/2023
- Keywords
- Low-density lipoprotein cholesterol (LDL-C), LDL-C targets, ASCVD risk levels, Middle East population
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No enough patients to be enrolled
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Collaborators
- The Cardiovascular Academy Group of the JCS, The Jordan Cardiac Society (JCS), Istishari Hospital Department of Clinical Research
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Age 18-55 y
- Individuals can give a history of the presence or absence of ASCVD and its risk factors
Key exclusion criteria (2 listed)
- Age below 18 or older than 55
- Refusal of inability to give history on ASCVD and its risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
LDL-cholesterol blood level
Time frame: 12 months
Results and safety
The study was stopped early (reason given: No enough patients to be enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. CRF (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imad A. Alhaddad, MD FACC study chair
Department of Cardiology, Jordan Hospital, Amman, Jordan
Ramzi Tabbalat study director
Cardiology Department, Abdali Hospital
Ayman Hammoudeh, MD FACC principal investigator
Department of Clinical Research, Istishari Hospital, Aman, Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Risk and Low-density-lipoprotein (LDL) Cholesterol, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No enough patients to be enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk level of ASCVD (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.