NCT01458860

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

Same day

First QC Date

October 24, 2011

Last Update Submit

October 31, 2011

Conditions

Study Arms (2)

GROUP A

patients had a CT

GROUP B

patients with severe carotid artery stenosis

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Group A - age \<40 years
  • Group B - carotid artery stenosis, without intention-to-treat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tal Salamon, MD

    Zim medical center

    PRINCIPAL INVESTIGATOR
  • Alexander Altsuler, MD

    Ziv Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 25, 2011

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2014

Last Updated

November 1, 2011

Record last verified: 2011-10