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

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01458860
• Other study ID #: ZIV-11-0041
• Status: Not yet recruiting
• Phase: N/A
• First received: October 24, 2011
• Last updated: October 31, 2011
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2011
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Calcification
• Calcinosis
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital