Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk

Atherosclerosis of Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499496
• Other study ID #: DPitarch
• Status: Completed
• First received: March 22, 2018
• Last updated: April 9, 2018
• Start date: January 15, 2016
• Est. completion date: September 4, 2016

Study information

• Verified date: April 2018
• Source: Cabinet de Medecine Interne Générale Demetrio Pitarch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 4, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 41 Years to 72 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• cardiovascular disease

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Artery

Intervention

Diagnostic Test:
• ultrasound guided detection of atherosclerotic plaques
screening by ultrasound of atherosclerotic plaques

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cabinet de Medecine Interne Générale Demetrio Pitarch

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of plaques in cardiovascular low risk population	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