Risk Factors in Young Middle Eastern Women With Cardiovascular Disease

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Risk Factors
• Intervention / Treatment: Other: Observing cardiovascular risk factors

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 Type: Observational
• Enrollment (Actual): 627

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11880
    • Istishari Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Women aged 18 y or more.
• Documented CVD (CAD stable or ACS, PCI, CABG, CVA/TIA, carotid disease, PAD).

Exclusion Criteria:

• Women younger than 18 years of age.
• No documented CVD.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young Women; Young women, aged 18 to 50 years, with documented atherosclerotic cardiovascular disease	Other: Observing cardiovascular risk factors; Documenting the presence or absence of CVD risk factors in each participant.
Older Women; Older women, aged >50 years, with documented atherosclerotic cardiovascular disease	Other: Observing cardiovascular risk factors; Documenting the presence or absence of CVD risk factors in each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	August 2021 to September 2020.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	August 2021 to September 2022.

Collaborators and Investigators

• Sponsor: Jordan Collaborating Cardiology Group
• Investigators: Study Director: Reham Nasseddin, MD, Jordan Collaborating Cardiology Group; Study Director: Laith N Habahbeh, MD, Jordan Collaborating Cardiology Group

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2021
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Risk factors; Atherosclerotic cardiovascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IH/JCCG1-RFYW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No