Atherosclerosis of ArteryNCT03499496
Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk
An observational study of Atherosclerosis of Artery, run by Cabinet de Medecine Interne Générale Demetrio Pitarch.
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… Read more about this study
- Who is it for?
- Ages 41 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis of Artery
- What is being tested?
- ultrasound guided detection of atherosclerotic plaques
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 4 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- low cardiovascular risk assessed by the AGLA/GSLA-score
Who cannot join
- cardiovascular disease
About this study
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
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.
Read the 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.
- Conditions
- Atherosclerosis of Artery
- Being tested
- ultrasound guided detection of atherosclerotic plaques
- Keywords
- plaques detection by ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided detection of atherosclerotic plaquesDiagnostic test
screening by ultrasound of atherosclerotic plaques
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start15 Jan 2016
- Primary completion30 Aug 2016
- Study completion4 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis of ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cabinet de Medecine Interne Générale Demetrio Pitarch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetrio A Pitarch, MD, Principal investigator, Cabinet de medecine generale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499496
- Sponsor's protocol ID
- DPitarch
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03499496
- Acronym / sponsor ID
- DPitarch
- Conditions
- Atherosclerosis of Artery
- Keywords
- plaques detection by ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cabinet de Medecine Interne Générale Demetrio PitarchUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 4 Sep 2016 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 41 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- low cardiovascular risk assessed by the AGLA/GSLA-score
Key exclusion criteria (1 listed)
- cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided detection of atherosclerotic plaquesscreening by ultrasound of atherosclerotic plaques | Diagnostic test | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetrio A Pitarch, MD principal investigator
Cabinet de medecine generale
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis of Artery, run by Cabinet de Medecine Interne Générale Demetrio Pitarch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of plaques in cardiovascular low risk population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.