Cardiovascular Patients With no Standard Modifiable Risk Factors (SMuRF-less-ME1)

January 29, 2024 updated by: Jordan Collaborating Cardiology Group

Absence of Standard Modifiable Risk Factors Among 5000 Middle Eastern Patients With Atherosclerotic Cardiovascular Disease: Clinical Profiles and Prevalence of Other Risk Factors and Comorbidities

A growing number of patients develop atherosclerotic cardiovascular disease (ASCVD) despite the absence of standard modifiable risk factors (SMuRF-less). There is scarcity of studies that address this issue in the Middle Eastern population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Atherosclerotic coronary artery disease (ASCAD) claims millions of lives annually on a global level and is the leading cause of death in the Middle East. There are four standard modifiable cardiovascular risk factors (SMuRFs): hypertension, type 2 diabetes mellitus, dyslipidemia, and smoking. These are very common in the Middle East and are crucial to be screened for and addressed in an affective manner.

However, an increasing proportion of patients with ASCVD have none of these individual factors (SMuRF-less). Globally, this proportion comprises 11.6% of individuals with stable coronary disease and heart attack. No prior study has addressed the issue of the prevalence of SMuRF-less patients among the whole population of individuals with ASCVD in the Middle East.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Ali Al-Halabi, MD
  • Phone Number: +00962795648342

Study Locations

  • Jordan
      • Amman, Jordan, 11184
        • Recruiting
        • Istishari Hospital
        • Contact:
      • Irbid, Jordan
        • Recruiting
        • Yarmouk University School of Medicine
        • Contact:
          • Mouaywah Al Khatatabeh, MD
          • Phone Number: +00962795648342

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

  1. Adults (18 years of age and older) with ASCVD.

  2. ASCVD includes:

    1. Coronary heart disease
    2. stroke
    3. peripheral artery disease.

Description

Inclusion Criteria:

  • A diagnosis of atherosclerotic cardiovascular disease (ASCVD).
  • Ability to fill the clinical form that evaluates the presence or absence of cardiovascular risk factors including the 4 SMuRFs.

Exclusion Criteria:

  • Atherosclerotic cardiovascular disease diagnosed before the age of 18 years.
  • Inability to give detailed history of prespecified 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
Prevalence of patients who do not any of the four SMuRFs
Time Frame: Up to 4 weeks after study enrollment
Group of patients with definite ASCVD who do not have hypertension, diabetes, dyslipidemia or smoking.
Up to 4 weeks after study enrollment

Collaborators and Investigators

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

Sponsor

Jordan Collaborating Cardiology Group

Collaborators

The Jordan Cardiovascular Research Group JoCVRG
Yarmouk University School of Medicine

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)

January 22, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 10, 2024

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVA2024.SMuRFless1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will invite physicians to recruit 5000 individuals with ASCVD starting 1-1-2024. Once the team is gathered will share the clinical form with the all participating physicians.

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.

Clinical Trials on Cardiovascular Risk Factors

Clinical Trials on Evaluation of risk factors by direct interview with subjects who have atherosclerotic cardiovascular patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe