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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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%.

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 groups in NCT06895265
Study groupRoleWhat they receive
Patients with abdominal CT recordsThe 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.

  1. 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.

  1. First posted26 Mar 2025
  2. Study start2 Feb 2024
  3. Primary completion30 Dec 2024
  4. Study completion1 Jan 2025

Resources

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)
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."

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.

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