Cardiovascular Risk FactorsSMuRF-less-ME1NCT06199869
Cardiovascular Patients With no Standard Modifiable Risk Factors
An observational study of Cardiovascular Risk Factors, run by Jordan Collaborating Cardiology Group at 2 sites in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Evaluation of risk factors by direct interview with subjects who have atherosclerotic cardiovascular patients
- How many people
- 5,540 participants
- Where
- 2 sitesJordan
- Study dates
- 22 Jan 2024to 31 Jan 2025
- 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
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Atherosclerotic cardiovascular disease diagnosed before the age of 18 years.
- Inability to give detailed history of prespecified risk factors.
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Istishari Hospital
Amman, 11184
Yarmouk University School of Medicine
Irbid
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Evaluation of risk factors by direct interview with subjects who have atherosclerotic cardiovascular patients
- Keywords
- Atherosclerotic cardiovascular disease, Standard modifiable risk factors (SMuRFs), Middle Eastern population
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of risk factors by direct interview with subjects who have atherosclerotic cardiovascular patientsOther
Individuals identified with a diagnosis of ASCVD will fill a one page form of the associated risk factors they have
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of patients who do not any of the four SMuRFs
Group of patients with definite ASCVD who do not have hypertension, diabetes, dyslipidemia or smoking.
Measured: Up to 4 weeks after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start22 Jan 2024
- Primary completion1 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Jordan Cardiovascular Research Group JoCVRG, Yarmouk University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199869
- Sponsor's protocol ID
- CVA2024.SMuRFless1
- Acronym
- SMuRF-less-ME1
- Status last verified
- Feb 2025
- First submitted
- 25 Dec 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Hammoudeh A, Aldalal'ah M, Al-Malkawi F, Haddad E, Rizik A, Shadeed O, Sulaiman S, Abughosh M, Marouf L, Abu Khalil Q, Shbita Z, Alhaj A, Hammoudeh JM, Araidah M. Redefining atherosclerotic cardiovascular disease patients with no standard modifiable risk factors "SMuRF-less": six rather than four risk factors. Analysis from the Jordan SMuRF-less Study. Front Cardiovasc Med. 2026 Aug 6;13:1785553. doi: 10.3389/fcvm.2026.1785553. eCollection 2026.
PubMed 42625571Alsheyyab J, Al Qtaish N, AbuZamzam H, Al-Saud WS, Al-Soud AS, Ahmed KA, Albekaen N, Bani Baker M, Musa R, Al Tawarh BY, Abualhayja'a AM, Kiwan B, Albakri MS, Omari O, Shukairi A, Albeka'en S, Mousa H, Al-Shudifat AE. A Cross-Sectional Analytical Study: Prevalence and Clinical Profile of Metabolic Syndrome Among Middle Eastern, Mainly Jordanians, Cohort Presented with Atherosclerotic Cardiovascular Disease. Vasc Health Risk Manag. 2026 Aug 5;22:583687. doi: 10.2147/VHRM.S583687. eCollection 2026.
PubMed 42572733Alrida NA, Albikawi Z, Alotaibi N, Alkouri O, Saifan AR, Jarrah M, Hammoudeh A, Khader Y, Alenezy A, Al-Zu'bi BM, Alharbi A, Alhalaiqa F, AbuRuz ME. Association of SMuRFs with cardiovascular risk factors, disease burden, and pharmacological management in Middle Eastern patients with ASCVD and a family history of premature CVD. Front Cardiovasc Med. 2025 Nov 27;12:1678767. doi: 10.3389/fcvm.2025.1678767. eCollection 2025.
PubMed 41393265Alkouri O, Alrida NA, Alabkal RM, Khader Y, Albikawi Z, Ababneh A, Alobaidly A, Qaladi O, Alharbi A, Jarrah M, Alotaibi N, Al-Bashaireh AM, Hammoudeh A, AbuRuz ME, Almustafa LA, Khraisat O, Al-Nsair N. Prevalence of physical activity and its association with atherosclerotic cardiovascular risk factors in young women in the middle east: a sub-analysis of the ANCHORS study. BMC Public Health. 2025 Oct 1;25(1):3268. doi: 10.1186/s12889-025-24595-y.
PubMed 41034877Hammoudeh AJ, Aldalal'ah M, Smadi EA, Alrishoud D, Alomari A, Alkhawaldeh M, Rizik A, Okour MF, Araydah M. Absence of Standard Modifiable Risk Factors in Middle Eastern Patients with Atherosclerotic Cardiovascular Disease. The Jordan Absence of Standard Modifiable Risk Factors (SMuRF-Less) Study. Vasc Health Risk Manag. 2025 Feb 5;21:39-50. doi: 10.2147/VHRM.S499355. eCollection 2025.
PubMed 39931041
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06199869
- Acronym / sponsor ID
- SMuRF-less-ME1 / CVA2024.SMuRFless1
- Conditions
- Cardiovascular Risk Factors
- Keywords
- Atherosclerotic cardiovascular disease, Standard modifiable risk factors (SMuRFs), Middle Eastern population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,540 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Collaborators
- The Jordan Cardiovascular Research Group JoCVRG, Yarmouk University School of Medicine
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 10 Jan 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Atherosclerotic cardiovascular disease diagnosed before the age of 18 years.
- Inability to give detailed history of prespecified 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of risk factors by direct interview with subjects who have atherosclerotic cardiovascular patientsIndividuals identified with a diagnosis of ASCVD will fill a one page form of the associated risk factors they have | Other | – |
Primary outcome
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.
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 25 Feb 2025.
- Derived from this study: PubMed 42625571Hammoudeh A, Aldalal'ah M, Al-Malkawi F, Haddad E, Rizik A, Shadeed O, Sulaiman S, Abughosh M, Marouf L, Abu Khalil Q, Shbita Z, Alhaj A, Hammoudeh JM, Araidah M. Redefining atherosclerotic cardiovascular disease patients with no standard modifiable risk factors "SMuRF-less": six rather than four risk factors. Analysis from the Jordan SMuRF-less Study. Front Cardiovasc Med. 2026 Aug 6;13:1785553. doi: 10.3389/fcvm.2026.1785553. eCollection 2026.
- Derived from this study: PubMed 42572733Alsheyyab J, Al Qtaish N, AbuZamzam H, Al-Saud WS, Al-Soud AS, Ahmed KA, Albekaen N, Bani Baker M, Musa R, Al Tawarh BY, Abualhayja'a AM, Kiwan B, Albakri MS, Omari O, Shukairi A, Albeka'en S, Mousa H, Al-Shudifat AE. A Cross-Sectional Analytical Study: Prevalence and Clinical Profile of Metabolic Syndrome Among Middle Eastern, Mainly Jordanians, Cohort Presented with Atherosclerotic Cardiovascular Disease. Vasc Health Risk Manag. 2026 Aug 5;22:583687. doi: 10.2147/VHRM.S583687. eCollection 2026.
- Derived from this study: PubMed 41393265Alrida NA, Albikawi Z, Alotaibi N, Alkouri O, Saifan AR, Jarrah M, Hammoudeh A, Khader Y, Alenezy A, Al-Zu'bi BM, Alharbi A, Alhalaiqa F, AbuRuz ME. Association of SMuRFs with cardiovascular risk factors, disease burden, and pharmacological management in Middle Eastern patients with ASCVD and a family history of premature CVD. Front Cardiovasc Med. 2025 Nov 27;12:1678767. doi: 10.3389/fcvm.2025.1678767. eCollection 2025.
- Derived from this study: PubMed 41034877Alkouri O, Alrida NA, Alabkal RM, Khader Y, Albikawi Z, Ababneh A, Alobaidly A, Qaladi O, Alharbi A, Jarrah M, Alotaibi N, Al-Bashaireh AM, Hammoudeh A, AbuRuz ME, Almustafa LA, Khraisat O, Al-Nsair N. Prevalence of physical activity and its association with atherosclerotic cardiovascular risk factors in young women in the middle east: a sub-analysis of the ANCHORS study. BMC Public Health. 2025 Oct 1;25(1):3268. doi: 10.1186/s12889-025-24595-y.
- Derived from this study: PubMed 39931041Hammoudeh AJ, Aldalal'ah M, Smadi EA, Alrishoud D, Alomari A, Alkhawaldeh M, Rizik A, Okour MF, Araydah M. Absence of Standard Modifiable Risk Factors in Middle Eastern Patients with Atherosclerotic Cardiovascular Disease. The Jordan Absence of Standard Modifiable Risk Factors (SMuRF-Less) Study. Vasc Health Risk Manag. 2025 Feb 5;21:39-50. doi: 10.2147/VHRM.S499355. eCollection 2025.
- Individual participant dataSharing planned: Undecided. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factors, run by Jordan Collaborating Cardiology Group at 2 sites 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 patients who do not any of the four SMuRFs (time frame: Up to 4 weeks after study enrollment). 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 NCT06199869, which also lists 5 linked publications.
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 25 Feb 2025.