Aortic Calcification - is it a Marker for Carotid Artery Stenosis?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01458860
First received: October 24, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

Atherosclerosis is the major contributor for the morbidity and mortality for the variety of cardiovascular diseases.

Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent prognostic factor for the morbidity and mortality from a cardiovascular event.

Carotid artery stenoses is the current accepted indication for interventional treatment of carotid artery, for the prevention of embolic event, while other arterial atherosclerosis indication, is for hemodynamic disturbance and ischemic outcome.

This research will try to find whether incidental aortic calcification can predict carotid artery stenosis.

Two groups will be chosen: group A - patients who had CT scan in the hospital (for different indications); Group B - patients (not from the first group) who have a significant carotid artery stenosis who are indicated for interventional treatment.

The data to analyze:

Group A - Patients with aortic calcification, carotid artery stenosis, and patients with both Group B - Patients who have aortic calcification Comparison of the populations within the group and among the two will show if a significant correlation between aortic calcification and carotid artery stenosis exist.


Condition
Carotid Artery Stenosis
Aortic Calcification

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Aortic Calcification - is it a Marker for Carotid Artery Stenosis?

Further study details as provided by Ziv Hospital:

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
GROUP A
patients had a CT
GROUP B
patients with severe carotid artery stenosis

Detailed Description:

Background - thoracic or abdominal aortic calcification is a documented independent risk factor for cardiovascular atherosclerotic disease and increased death.

Atherosclerosis is a diffuse multicentric disease in the arterial tree, affecting target organs (heart, aorta, lower extremities, carotid arteries etc.). Mostly located in arterial bifurcations (Iliac and carotid artery bifurcations) or in constant repetitive arterial trauma (Adductors tendon, Hunter's canal). The invasive treatment (endovascular, surgery) is preserved for patients with critical arterial stenosis or occlusion in symptomatic patients. Exceptions are the carotid arteries: the majority of patients with a severe internal carotid artery stenosis are asymptomatic patients, which are treated for the prevention embolic events (TIA's or CVA's).

Current articles are observational, and describe retrospectively the morbidity and mortality from atherosclerosis with aortic calcification.

the investigators assumption is that if aortic calcification is a marker for diffuse atherosclerosis, it has good correlation to criptogenous carotid artery disease, and can lead to early carotid artery disease evaluation and treatment.

Purpose - to find a reliable correlation between aortic calcification, and carotid artery stenosis (from atherosclerosis)

Method - two groups will be evaluated:

Group A - patients (age >40 years), that had a CT scan (chest/abdomen) for any indication, will be evaluated for aortic calcifications. The patients will be additionally examined for carotid artery stenosis by Doppler ultrasound. (100 patients) Group B - Patients that were diagnosed by Doppler ultrasound, and were found to have a severe carotid artery stenosis. These patients are scheduled for a computed tomography-angiography (regardless for the research) of the cervical arteries, will be additionally complete abdominal/chest tomography scan, without additional contrast. (50 patients).

Results - will be statistically evaluated - Group A - number of patients with aortic calcification, number of patients with carotid artery stenosis; Group B - Number of patients that have associated aortic calcification.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group A - patients who had a CT scan Group B - patients who have severe carotid artery stenosis

Criteria

Inclusion Criteria:

Group A - patients, age 40-99 years, that had a CT scan for any indication Group B - patients with severe carotid artery stenosis, that indicated for treatment

Exclusion Criteria:

  • Group A - age <40 years
  • Group B - carotid artery stenosis, without intention-to-treat
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458860

Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Tal Salamon, MD Zim medical center
Study Director: Alexander Altsuler, MD Ziv Medical Center
  More Information

No publications provided

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01458860     History of Changes
Other Study ID Numbers: ZIV-11-0041
Study First Received: October 24, 2011
Last Updated: October 31, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Calcinosis
Carotid Stenosis
Constriction, Pathologic
Arterial Occlusive Diseases
Brain Diseases
Calcium Metabolism Disorders
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Metabolic Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014