Cardiovascular DiseasesNCT04975503
Risk Factors in Young Middle Eastern Women With Cardiovascular Disease
An observational study of Cardiovascular Diseases and Risk Factors, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial summary
Cardiovascular disease continues to be the leading cause of death among women in the Middle East, including Jordan. Sex-specific data focused on cardiovascular disease have been increasing steadily, yet is not the subgroup of young women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases, Risk Factors
- What is being tested?
- Observing cardiovascular risk factors
- How many people
- 627 participants
- Where
- 1 siteJordan
- Study dates
- 22 Aug 2021to 31 Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The prevalence of the 4 classical risk factors (HTN, DM, smoking, and dyslipidemia) will be studied in young women (younger than 50 years of age, and older than 18 y of age) who have documented CVD in ambulatory and in-patient settings. This data will be compared with those from women older than 50 y of age with CVD.
Who may be able to join
- Women aged 18 y or more.
- Documented CVD (CAD stable or ACS, PCI, CABG, CVA/TIA, carotid disease, PAD).
Who cannot join
- Women younger than 18 years of age.
- No documented CVD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Classical Risk Factors in Young Middle Eastern Women With Atherosclerotic Cardiovascular Disease
Cardiovascular disease continues to be the leading cause of death among women in the Middle East, including Jordan. Sex-specific data focused on cardiovascular disease have been increasing steadily, yet is not the subgroup of young women. This study focuses on classical and novel risk factors of cardiovascular disease in young women compared with older women.
Read the detailed description
This is the introduction of a new study at Istishari entitled: "The Classical Risk Factors in Young Middle Eastern Women with Atherosclerotic Cardiovascular Disease" This is an investigator-initiated, cross-sectional, non-interventional, observational study.
Medical research in Jordan is a basic responsibility of all medical sectors in the country. Despite the drastic growth and advances of medical services, the volume of the local medical research is, at best estimate, scarce. The emerging role of private medical groups, private hospitals, and residency programs in cooperation with other medical sectors and medical schools, in conducting, presenting, and publishing such studies should be encouraged and supported. A major indicator of judging the credibility and quality of any medical research project is to look at the conferences the research was presented at and the journals it was published in.
This is the 10th major project of the Jordan Collaborating Cardiology Group (JCC) and the first in cooperation with the Istishari Hospital Internal Medicine Residency Program (see Appendix 1. Timeline of JCC Group studies) The first project was JoHARTS that evaluated coronary risk factors and dyslipidemia in 5000 individuals with ACS, stable CAD, and non CAD patients. The 2nd project was CAPRIS evaluated the prognostic implications of hs-CRP in ACS from admission to 1 year. The 3rd project was MINTOR that evaluated onset, triggers, reperfusion strategies, and hospital mortality in more than 950 Jordanians with acute ST-elevation MI. The 4th project was GLORY study that evaluated the prevalence of glucometabolic states among ACS patients, prognosis up to 1 year, and TIMI risk score . The 5th was JoPCR1 that evaluated outcome post PCI in 2426 ACS and non ACS patients in 12 tertiary care centers for the incidence of death, stent thrombosis, revascularization, bleeding, impact of gender, DM, renal dysfunction, and age on outcome, GRACE, and CRUSADE risk scores. The 6th is the colchicine study of AF prevention in open heart surgery, one is completed with 1 mg dose and one is ongoing with reduced dose. The 7th and 8th projects are ongoing and study statin eligibility in patients admitted with MI (Statin EPIC) and decade or more survivors after coronary revascularization. The 8th was the Jordanian AF study which evaluated patients with AF in ambulatory and out-patient settings. The 9th was the JoCORE study that evaluated acute CV events due to the stresses of the covid-19 pandemic.
One population subgroup is under studied in the world literature as well as the local literature. The young women who have documented CVD. This group represents only a small proportion of the CVD population in all countries.
- Conditions
- Cardiovascular Diseases, Risk Factors
- Being tested
- Observing cardiovascular risk factors
- Keywords
- Atherosclerotic cardiovascular disease, Risk factors
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observing cardiovascular risk factorsOther
Documenting the presence or absence of CVD risk factors in each participant.
| Study group | Role | What they receive |
|---|---|---|
| Young Women | Young women, aged 18 to 50 years, with documented atherosclerotic cardiovascular disease Receives: Other: Observing cardiovascular risk factors | |
| Older Women | Older women, aged >50 years, with documented atherosclerotic cardiovascular disease Receives: Other: Observing cardiovascular risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of classical CVD risk factors
To study the prevalence of the 4 classical risk factors (HTN, DM, smoking, and dyslipidemia) in young women (younger than 50 years of age) who have documented CVD in ambulatory and in-patient settings and compare the data with women older than 50 y of age with CVD.
Measured: August 2021 to September 2020.
Secondary outcomes (1)
Prevalence of novel/emerging CVD risk factors
To study emerging non traditional risk factors, and demographic baseline features of these patients including family history, BMI, PCOS, hormone medications, sport activities.. etc.
Measured: August 2021 to September 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start22 Aug 2021
- Primary completion30 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman J Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group
- Investigators
- Reham Nasseddin, MD, Study director, Jordan Collaborating Cardiology GroupLaith N Habahbeh, MD, Study director, Jordan Collaborating Cardiology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975503
- Sponsor's protocol ID
- IH/JCCG1-RFYW
- Status last verified
- Jan 2024
- First submitted
- 14 Jul 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will be retained with the PI and not shared. Clinical forms with participant initials, rather than full names, will be shared for analysis.
Publications
Hammoudeh AJ, Jallad M, Khader Y, Badaineh Y, Tabbalat RA, Zammar H, Al-Makhamreh H, Basha A, AlAtteili L, Abuhalimeh R, Fkheideh T, Ababneh A, Ababneh L, Mahmoud SA, Alhaddad IA. Atherosclerotic Cardiovascular Disease Novel and Traditional Risk Factors in Middle Eastern Young Women. The ANCORS-YW Study. Glob Heart. 2024 Jul 15;19(1):59. doi: 10.5334/gh.1341. eCollection 2024.
PubMed 39035774
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classical Risk Factors in Young Middle Eastern Women With Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04975503
- Acronym / sponsor ID
- IH/JCCG1-RFYW
- Conditions
- Cardiovascular Diseases, Risk Factors
- Keywords
- Atherosclerotic cardiovascular disease, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 22 Aug 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Jul 2021 (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.
Cardiovascular disease continues to be the leading cause of death among women in the Middle East, including Jordan. Sex-specific data focused on cardiovascular disease have been increasing steadily, yet is not the subgroup of young women. This study focuses on classical and novel risk factors of cardiovascular disease in young women compared with older women.
Detailed description
This is the introduction of a new study at Istishari entitled: "The Classical Risk Factors in Young Middle Eastern Women with Atherosclerotic Cardiovascular Disease" This is an investigator-initiated, cross-sectional, non-interventional, observational study.
Medical research in Jordan is a basic responsibility of all medical sectors in the country. Despite the drastic growth and advances of medical services, the volume of the local medical research is, at best estimate, scarce. The emerging role of private medical groups, private hospitals, and residency programs in cooperation with other medical sectors and medical schools, in conducting, presenting, and publishing such studies should be encouraged and supported. A major indicator of judging the credibility and quality of any medical research project is to look at the conferences the research was presented at and the journals it was published in.
This is the 10th major project of the Jordan Collaborating Cardiology Group (JCC) and the first in cooperation with the Istishari Hospital Internal Medicine Residency Program (see Appendix 1. Timeline of JCC Group studies) The first project was JoHARTS that evaluated coronary risk factors and dyslipidemia in 5000 individuals with ACS, stable CAD, and non CAD patients. The 2nd project was CAPRIS evaluated the prognostic implications of hs-CRP in ACS from admission to 1 year. The 3rd project was MINTOR that evaluated onset, triggers, reperfusion strategies, and hospital mortality in more than 950 Jordanians with acute ST-elevation MI. The 4th project was GLORY study that evaluated the prevalence of glucometabolic states among ACS patients, prognosis up to 1 year, and TIMI risk score . The 5th was JoPCR1 that evaluated outcome post PCI in 2426 ACS and non ACS patients in 12 tertiary care centers for the incidence of death, stent thrombosis, revascularization, bleeding, impact of gender, DM, renal dysfunction, and age on outcome, GRACE, and CRUSADE risk scores. The 6th is the colchicine study of AF prevention in open heart surgery, one is completed with 1 mg dose and one is ongoing with reduced dose. The 7th and 8th projects are ongoing and study statin eligibility in patients admitted with MI (Statin EPIC) and decade or more survivors after coronary revascularization. The 8th was the Jordanian AF study which evaluated patients with AF in ambulatory and out-patient settings. The 9th was the JoCORE study that evaluated acute CV events due to the stresses of the covid-19 pandemic.
One population subgroup is under studied in the world literature as well as the local literature. The young women who have documented CVD. This group represents only a small proportion of the CVD population in all countries.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Women | – | Other: Observing cardiovascular risk factorsYoung women, aged 18 to 50 years, with documented atherosclerotic cardiovascular disease |
| Older Women | – | Other: Observing cardiovascular risk factorsOlder women, aged >50 years, with documented atherosclerotic cardiovascular disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The prevalence of the 4 classical risk factors (HTN, DM, smoking, and dyslipidemia) will be studied in young women (younger than 50 years of age, and older than 18 y of age) who have documented CVD in ambulatory and in-patient settings. This data will be compared with those from women older than 50 y of age with CVD.
Key inclusion criteria (2 listed)
- Women aged 18 y or more.
- Documented CVD (CAD stable or ACS, PCI, CABG, CVA/TIA, carotid disease, PAD).
Key exclusion criteria (2 listed)
- Women younger than 18 years of age.
- No documented CVD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observing cardiovascular risk factorsDocumenting the presence or absence of CVD risk factors in each participant. | Other | Older Women, Young Women |
Primary outcome
Prevalence of classical CVD risk factors
Time frame: August 2021 to September 2020.
To study the prevalence of the 4 classical risk factors (HTN, DM, smoking, and dyslipidemia) in young women (younger than 50 years of age) who have documented CVD in ambulatory and in-patient settings and compare the data with women older than 50 y of age with CVD.
1 secondary outcome
Prevalence of novel/emerging CVD risk factors
Time frame: August 2021 to September 2022.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 39035774Hammoudeh AJ, Jallad M, Khader Y, Badaineh Y, Tabbalat RA, Zammar H, Al-Makhamreh H, Basha A, AlAtteili L, Abuhalimeh R, Fkheideh T, Ababneh A, Ababneh L, Mahmoud SA, Alhaddad IA. Atherosclerotic Cardiovascular Disease Novel and Traditional Risk Factors in Middle Eastern Young Women. The ANCORS-YW Study. Glob Heart. 2024 Jul 15;19(1):59. doi: 10.5334/gh.1341. eCollection 2024.
- Individual participant dataSharing planned: No. The individual participant data will be retained with the PI and not shared. Clinical forms with participant initials, rather than full names, will be shared for analysis.
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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.
Reham Nasseddin, MD study director
Jordan Collaborating Cardiology Group
Laith N Habahbeh, MD study director
Jordan Collaborating Cardiology Group
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 Cardiovascular Diseases and Risk Factors, 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: finished, as of the sponsor's last update on 30 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of classical CVD risk factors (time frame: August 2021 to September 2020.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04975503, which also lists 1 linked publication.
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 30 Jan 2024.