Vascular CalcificationPCTBACNCT06895265
Potential Cross-Talk Between Arterial Calcifications
An observational study of Vascular Calcification and Atherosclerosis of Artery, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Potential Cross-Talk Between Arterial Calcifications Background Vascular calcification is a key component of atherosclerosis. This study investigates the potential correlations between aortic and coronary calcifications detected via abdominal CT, considering age-related variations, to explore the possibility of… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Vascular Calcification, Atherosclerosis of Artery
- How many people
- 921 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2024to 1 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 40-90 with non-contrast abdominal CT records.
Who may be able to join
- Hypertension, Hyperlipidemia, Diabetes Mellitus, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease
Who cannot join
- Chronic renal failure Hemodialysis patients
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatoryum RTH
Ankara, Türki̇ye, 06570
About this study
Official title: Cross-Talk Between Arterial Calcifications
Potential Cross-Talk Between Arterial Calcifications Background Vascular calcification is a key component of atherosclerosis. This study investigates the potential correlations between aortic and coronary calcifications detected via abdominal CT, considering age-related variations, to explore the possibility of cross-talk.
Method A total of 921 patients (n=921) [male: 508 (55%), female: 413 (44.7%)] were divided into three age groups: 40-49, 50-69, and 70-90 years. Non-contrast abdominal CT scans were evaluated for calcifications in the coronary arteries, thoracic aorta, abdominal aorta (AA(1): suprarenal, AA(2): renal, AA(3): infrarenal), iliac arteries, and femoral artery. Aortic branches were categorized by calcification levels: none, <25%, 25-50%, ≥50%
Read the detailed description
Atherosclerosis, a chronic inflammatory condition characterized by the buildup of plaque in the arteries, remains a major global health challenge. Vascular calcification (VC) is a critical component of atherosclerosis . VC can reduce the flexibility and compliance of the blood vessel wall, increase the instability of atherosclerotic plaque, and contribute to intravascular blood clotting, vascular obstruction, heart failure, and acute myocardial infarction. Furthermore, it can exacerbate cardiac workload .
Mediators from peripheral tissues, including inflammation and pro-inflammatory cytokines, are released into the circulation and may affect the heart. Coronary artery disease (CAD) also prompts the heart to release pro-inflammatory cytokines into the bloodstream. Cardiokines, which are heart-derived cytokines, can exert significant endocrine effects on other tissues, leading to damage in various peripheral organs .
Extracellular vesicles (EVs), which attach to receptor cell surfaces, can directly facilitate signal transmission or transfer their contents into the cell to elicit a functional response. EVs have been associated with subclinical atherosclerosis, which is diagnosed through ultrasound imaging of the femoral artery, carotid artery, or abdominal aorta . They have also been shown to play a role in the VC process. EVs facilitate communication between vascular wall cells and bone-vascular, liver-vascular, and adipose-vascular cells to regulate VC .
Understanding the relationship between calcification formations across different arterial regions is crucial for improving our knowledge of atherosclerosis pathophysiology and for facilitating the early diagnosis and follow-up of other affected regions. If such an association exists, it could provide valuable insights into systemic vascular diseases, ischemic patterns, and organ-specific perfusion dynamics.
Methods Patient selection and data collection Non-contrast abdominal CT records of 1,100 patients were reviewed. Records that included observable coronary sections starting from the aorta and femoral artery sections were included in the study. A total of 921 patients [male: 508 (55%), female: 413 (44.7%)] met the inclusion criteria and were divided into three age groups: 40-49, 50-69, and 70-90 years. Patients were classified into subgroups based on their medical records for Hypertension, Hyperlipidemia, Diabetes Mellitus, Coronary Artery Disease, and Chronic Obstructive Pulmonary Disease.
The CT records were retrospectively evaluated for calcifications in the coronary arteries, thoracic and abdominal aorta [AA] [suprarenal [1], renal [2], and infrarenal [3] segments], common iliac arteries [Communis], internal and external iliac arteries [Iliac], and femoral arteries.The CAC score is commonly used to quantify the extent of calcification across all coronary arteries and is typically categorized on a per-patient basis as None, Mild, Moderate, or Severe Following the examination of coronary lesions and the thoracic aorta for calcification, the abdominal aortic area was analyzed. Aortic calcifications were classified in horizontal cross-sectional slices, to some extent, in accordance with the classification proposed by Ehara et alRegional vessel segments were evaluated based on the extent of calcification and categorized as: none, <25%, 25-50%, and ≥50-100%.
- Conditions
- Vascular Calcification, Atherosclerosis of Artery
- Keywords
- Vascular calcification
- Medical subject headings
- Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with abdominal CT records | The study group consisted of non-contrast abdominal CT records from 921 patients, aged between 40 and 90 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of coronary and abdominal aorta, as well as common, iliac, and femoral artery calcifications.
1-coronary artery calcifications, (CAC)] were visually classified in a simplified manner as either present or absent for a faster assessment 2-Following the examination of coronary lesions and the thoracic aorta for calcification, the abdominal aortic area was analyzed. Aortic calcifications were classified in horizontal cross-sectional slices.Regional vessel segments were evaluated based on the extent of calcification and categorized as: none, <25%, 25-50%, and ≥50-100%.
Measured: "Data were collected over a period of ten months."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start2 Feb 2024
- Primary completion30 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şahbender Koç, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895265
- Sponsor's protocol ID
- 18.2.2024/66
- Acronym
- PCTBAC
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared only upon reasonable request and approval by the study sponsor."
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Talk Between Arterial Calcifications
- ClinicalTrials.gov ID
- NCT06895265
- Acronym / sponsor ID
- PCTBAC / 18.2.2024/66
- Conditions
- Vascular Calcification, Atherosclerosis of Artery
- Keywords
- Vascular calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 26 Mar 2025 (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.
Potential Cross-Talk Between Arterial Calcifications Background Vascular calcification is a key component of atherosclerosis. This study investigates the potential correlations between aortic and coronary calcifications detected via abdominal CT, considering age-related variations, to explore the possibility of cross-talk.
Method A total of 921 patients (n=921) [male: 508 (55%), female: 413 (44.7%)] were divided into three age groups: 40-49, 50-69, and 70-90 years. Non-contrast abdominal CT scans were evaluated for calcifications in the coronary arteries, thoracic aorta, abdominal aorta (AA(1): suprarenal, AA(2): renal, AA(3): infrarenal), iliac arteries, and femoral artery. Aortic branches were categorized by calcification levels: none, <25%, 25-50%, ≥50%
Detailed description
Atherosclerosis, a chronic inflammatory condition characterized by the buildup of plaque in the arteries, remains a major global health challenge. Vascular calcification (VC) is a critical component of atherosclerosis . VC can reduce the flexibility and compliance of the blood vessel wall, increase the instability of atherosclerotic plaque, and contribute to intravascular blood clotting, vascular obstruction, heart failure, and acute myocardial infarction. Furthermore, it can exacerbate cardiac workload .
Mediators from peripheral tissues, including inflammation and pro-inflammatory cytokines, are released into the circulation and may affect the heart. Coronary artery disease (CAD) also prompts the heart to release pro-inflammatory cytokines into the bloodstream. Cardiokines, which are heart-derived cytokines, can exert significant endocrine effects on other tissues, leading to damage in various peripheral organs .
Extracellular vesicles (EVs), which attach to receptor cell surfaces, can directly facilitate signal transmission or transfer their contents into the cell to elicit a functional response. EVs have been associated with subclinical atherosclerosis, which is diagnosed through ultrasound imaging of the femoral artery, carotid artery, or abdominal aorta . They have also been shown to play a role in the VC process. EVs facilitate communication between vascular wall cells and bone-vascular, liver-vascular, and adipose-vascular cells to regulate VC .
Understanding the relationship between calcification formations across different arterial regions is crucial for improving our knowledge of atherosclerosis pathophysiology and for facilitating the early diagnosis and follow-up of other affected regions. If such an association exists, it could provide valuable insights into systemic vascular diseases, ischemic patterns, and organ-specific perfusion dynamics.
Methods Patient selection and data collection Non-contrast abdominal CT records of 1,100 patients were reviewed. Records that included observable coronary sections starting from the aorta and femoral artery sections were included in the study. A total of 921 patients [male: 508 (55%), female: 413 (44.7%)] met the inclusion criteria and were divided into three age groups: 40-49, 50-69, and 70-90 years. Patients were classified into subgroups based on their medical records for Hypertension, Hyperlipidemia, Diabetes Mellitus, Coronary Artery Disease, and Chronic Obstructive Pulmonary Disease.
The CT records were retrospectively evaluated for calcifications in the coronary arteries, thoracic and abdominal aorta [AA] [suprarenal [1], renal [2], and infrarenal [3] segments], common iliac arteries [Communis], internal and external iliac arteries [Iliac], and femoral arteries.The CAC score is commonly used to quantify the extent of calcification across all coronary arteries and is typically categorized on a per-patient basis as None, Mild, Moderate, or Severe Following the examination of coronary lesions and the thoracic aorta for calcification, the abdominal aortic area was analyzed. Aortic calcifications were classified in horizontal cross-sectional slices, to some extent, in accordance with the classification proposed by Ehara et alRegional vessel segments were evaluated based on the extent of calcification and categorized as: none, <25%, 25-50%, and ≥50-100%.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with abdominal CT records | – | –The study group consisted of non-contrast abdominal CT records from 921 patients, aged between 40 and 90 years. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 40-90 with non-contrast abdominal CT records.
Key inclusion criteria (1 listed)
- Hypertension, Hyperlipidemia, Diabetes Mellitus, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease
Key exclusion criteria (2 listed)
- Chronic renal failure Hemodialysis patients
- -
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
Recording of coronary and abdominal aorta, as well as common, iliac, and femoral artery calcifications.
Time frame: "Data were collected over a period of ten months."
1-coronary artery calcifications, (CAC)] were visually classified in a simplified manner as either present or absent for a faster assessment 2-Following the examination of coronary lesions and the thoracic aorta for calcification, the abdominal aortic area was analyzed. Aortic calcifications were classified in horizontal cross-sectional slices.Regional vessel segments were evaluated based on the extent of calcification and categorized as: none, <25%, 25-50%, and ≥50-100%.
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 26 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD will be shared only upon reasonable request and approval by the study sponsor."
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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.
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 Vascular Calcification and Atherosclerosis of Artery, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 26 Mar 2025. 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 Turkey (Türkiye). 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?
Recording of coronary and abdominal aorta, as well as common, iliac, and femoral artery calcifications. (time frame: "Data were collected over a period of ten 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 26 Mar 2025.