NCT03499496

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

January 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

March 22, 2018

Last Update Submit

April 9, 2018

Conditions

Atherosclerosis of Artery

Keywords

plaques detection by ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

ultrasound guided detection of atherosclerotic plaquesDIAGNOSTIC_TEST

screening by ultrasound of atherosclerotic plaques

Eligibility Criteria

Age41 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Demetrio A Pitarch, MD

    Cabinet de medecine generale

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 17, 2018

Study Start

January 15, 2016

Primary Completion

August 30, 2016

Study Completion

September 4, 2016

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share