Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk

April 9, 2018 updated by: Cabinet de Medecine Interne Générale Demetrio Pitarch

Prevalence of Atherosclerotic Carotid and/or Femoral Plaques in Patients Without Known Cardiovascular Disease and at Low-risk for Major Cardiovascular Events (AGLA/GLSA Score) Visiting a Private Primary Healthcare Practice in Switzerland

Cardiovascular disease is a common diagnosed and treated condition in private practices of primary health care. There is growing evidence that atherosclerotic plaques as predictors for stroke and heart attack are more prevalent than expected based on the clinical score in people with low risk for stroke and heart attack .

Diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be prescribed even if the clinical risk score is low or on the other hand if they can be observed even in high lipid levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Both common and proximal internal carotid arteries and both common femoral arteries (including bifurcations) were screened by ultrasound in patients who came for a check-up to a primary care practice with no known cardiovascular disease and low risk for stroke and heart attack according to the AGLA/GSLA risk score which is mostly used in Switzerland.

All patients agreed and gave written informed consent to be included in this study. Presence of plaques was defined as a focal carotid intima-media thickness >0.5 cm on ultrasound. Screening was performed by a medical doctor (DP) certified for the procedure using the following ultrasound system: Toshiba Nemio XG, probe 7.5 MhZ.

Study Type

Observational

Enrollment (Actual)

22

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The carotid and femoral arteries of 22 asymptomatic patients (9 females,13 males) aged between 41-72 having a low cardiovascular risk score based on blood pressure, nicotine abuse history, cardiac family history, blood analysis in fasting state for diabetes, lipid status including total cholesterol HDL-cholesterol, triglycerides and calculated LDL-cholesterol were screened by ultrasound.

Description

Inclusion Criteria:

  • low cardiovascular risk assessed by the AGLA/GSLA-score

Exclusion Criteria:

  • cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of plaques in cardiovascular low risk population
Time Frame: 1 year
Number of participants with the presence of carotid and/or femoral atherosclerotic plaques diagnosed via ultrasound (defined as a focal intima-media thickness >0.5 cm on ultrasound).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cabinet de Medecine Interne Générale Demetrio Pitarch

Investigators

  • Principal Investigator: Demetrio A Pitarch, MD, Cabinet de médecine générale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2016

Primary Completion (Actual)

August 30, 2016

Study Completion (Actual)

September 4, 2016

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPitarch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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