ArteriosclerosisNCT00863967
Early Detection of Arteriosclerosis
An observational study of Arteriosclerosis and Atherosclerosis, run by Kantonsspital Baselland Bruderholz.
Trial summary
Arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis, Atherosclerosis, Myocardial Infarction
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: teaching hospital primary care clinic
Who may be able to join
- 18 years and older
- informed consent
Who cannot join
- life-threatening disease
- life expectancy < 1 month
- uncapable to provide informed consent
About this study
Official title: Prospective Observational Cohort Study for Early Detection of Arteriosclerosis
Arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to life-style factors there is also a genetic predisposition to develop complicated atherosclerosis.
Objective: Improve individual risk prediction by clinical phenotyping and genotyping.
Read the detailed description
About 300 patients who are treated for various conditions at the department of general medicine at our hospital will be included prospectively in the study. This observational cohort will be followed for at least 10 years follow-up examinations.
At baseline and during follow up visits detailed clinical phenotyping is planned (medical and family history,standardized clinical and physical examinations, lab, RX, ECG, stress-test or echocardiogram). The genotyping is performed by DNA-isolation from leucocytes collected at baseline.
- Conditions
- Arteriosclerosis, Atherosclerosis, Myocardial Infarction, Stroke, Diabetes Mellitus, Peripheral Arterial Occlusive Disease
- Keywords
- physical examination, diagnostic techniques and procedures, diagnosis, immunologic tests, diagnostic tests, causality, genetic test, biomarker
- Medical subject headings
- Arteriosclerosis, Atherosclerosis, Myocardial Infarction, Stroke, Diabetes Mellitus, Peripheral Arterial Occlusive Disease 1, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | no cardiovascular events | |
| 2 | proven cardiovascular events | |
| 3 | possible cardiovascular events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Measured: 10 years at least
Secondary outcomes (1)
Disease activity score
Measured: 2 / 5 / 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startOct 2003
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ArteriosclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Biedermann, MD, Principal investigator, Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863967
- Sponsor's protocol ID
- KSBH: 216/03
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 18 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Biedermann BC, Sahner S, Gregor M, Tsakiris DA, Jeanneret C, Pober JS, Gratwohl A. Endothelial injury mediated by cytotoxic T lymphocytes and loss of microvessels in chronic graft versus host disease. Lancet. 2002 Jun 15;359(9323):2078-83. doi: 10.1016/S0140-6736(02)08907-9.
PubMed 12086762Binder CJ, Chang MK, Shaw PX, Miller YI, Hartvigsen K, Dewan A, Witztum JL. Innate and acquired immunity in atherogenesis. Nat Med. 2002 Nov;8(11):1218-26. doi: 10.1038/nm1102-1218. No abstract available.
PubMed 12411948Kiechl S, Lorenz E, Reindl M, Wiedermann CJ, Oberhollenzer F, Bonora E, Willeit J, Schwartz DA. Toll-like receptor 4 polymorphisms and atherogenesis. N Engl J Med. 2002 Jul 18;347(3):185-92. doi: 10.1056/NEJMoa012673.
PubMed 12124407Nabel EG. Cardiovascular disease. N Engl J Med. 2003 Jul 3;349(1):60-72. doi: 10.1056/NEJMra035098. No abstract available.
PubMed 12840094Nakajima T, Schulte S, Warrington KJ, Kopecky SL, Frye RL, Goronzy JJ, Weyand CM. T-cell-mediated lysis of endothelial cells in acute coronary syndromes. Circulation. 2002 Feb 5;105(5):570-5. doi: 10.1161/hc0502.103348.
PubMed 11827921Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164Stemme S, Faber B, Holm J, Wiklund O, Witztum JL, Hansson GK. T lymphocytes from human atherosclerotic plaques recognize oxidized low density lipoprotein. Proc Natl Acad Sci U S A. 1995 Apr 25;92(9):3893-7. doi: 10.1073/pnas.92.9.3893.
PubMed 7732003Strong JP, Malcom GT, McMahan CA, Tracy RE, Newman WP 3rd, Herderick EE, Cornhill JF. Prevalence and extent of atherosclerosis in adolescents and young adults: implications for prevention from the Pathobiological Determinants of Atherosclerosis in Youth Study. JAMA. 1999 Feb 24;281(8):727-35. doi: 10.1001/jama.281.8.727.
PubMed 10052443Yamada Y, Izawa H, Ichihara S, Takatsu F, Ishihara H, Hirayama H, Sone T, Tanaka M, Yokota M. Prediction of the risk of myocardial infarction from polymorphisms in candidate genes. N Engl J Med. 2002 Dec 12;347(24):1916-23. doi: 10.1056/NEJMoa021445.
PubMed 12477941
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study for Early Detection of Arteriosclerosis
- ClinicalTrials.gov ID
- NCT00863967
- Acronym / sponsor ID
- KSBH: 216/03
- Conditions
- Arteriosclerosis, Atherosclerosis, Myocardial Infarction, Stroke, Diabetes Mellitus, Peripheral Arterial Occlusive Disease
- Keywords
- physical examination, diagnostic techniques and procedures, diagnosis, immunologic tests, diagnostic tests, causality, genetic test, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 18 Mar 2009 (estimated)
- 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.
Arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to life-style factors there is also a genetic predisposition to develop complicated atherosclerosis.
Objective: Improve individual risk prediction by clinical phenotyping and genotyping.
Detailed description
About 300 patients who are treated for various conditions at the department of general medicine at our hospital will be included prospectively in the study. This observational cohort will be followed for at least 10 years follow-up examinations.
At baseline and during follow up visits detailed clinical phenotyping is planned (medical and family history,standardized clinical and physical examinations, lab, RX, ECG, stress-test or echocardiogram). The genotyping is performed by DNA-isolation from leucocytes collected at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –no cardiovascular events |
| 2 | – | –proven cardiovascular events |
| 3 | – | –possible cardiovascular events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- teaching hospital primary care clinic
Key inclusion criteria (2 listed)
- 18 years and older
- informed consent
Key exclusion criteria (3 listed)
- life-threatening disease
- life expectancy < 1 month
- uncapable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular events
Time frame: 10 years at least
1 secondary outcome
Disease activity score
Time frame: 2 / 5 / 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2009.
- Background: PubMed 12086762Biedermann BC, Sahner S, Gregor M, Tsakiris DA, Jeanneret C, Pober JS, Gratwohl A. Endothelial injury mediated by cytotoxic T lymphocytes and loss of microvessels in chronic graft versus host disease. Lancet. 2002 Jun 15;359(9323):2078-83. doi: 10.1016/S0140-6736(02)08907-9.
- Background: PubMed 12411948Binder CJ, Chang MK, Shaw PX, Miller YI, Hartvigsen K, Dewan A, Witztum JL. Innate and acquired immunity in atherogenesis. Nat Med. 2002 Nov;8(11):1218-26. doi: 10.1038/nm1102-1218. No abstract available.
- Background: PubMed 12124407Kiechl S, Lorenz E, Reindl M, Wiedermann CJ, Oberhollenzer F, Bonora E, Willeit J, Schwartz DA. Toll-like receptor 4 polymorphisms and atherogenesis. N Engl J Med. 2002 Jul 18;347(3):185-92. doi: 10.1056/NEJMoa012673.
- Background: PubMed 12840094Nabel EG. Cardiovascular disease. N Engl J Med. 2003 Jul 3;349(1):60-72. doi: 10.1056/NEJMra035098. No abstract available.
- Background: PubMed 11827921Nakajima T, Schulte S, Warrington KJ, Kopecky SL, Frye RL, Goronzy JJ, Weyand CM. T-cell-mediated lysis of endothelial cells in acute coronary syndromes. Circulation. 2002 Feb 5;105(5):570-5. doi: 10.1161/hc0502.103348.
- Background: PubMed 9887164Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
- Background: PubMed 7732003Stemme S, Faber B, Holm J, Wiklund O, Witztum JL, Hansson GK. T lymphocytes from human atherosclerotic plaques recognize oxidized low density lipoprotein. Proc Natl Acad Sci U S A. 1995 Apr 25;92(9):3893-7. doi: 10.1073/pnas.92.9.3893.
- Background: PubMed 10052443Strong JP, Malcom GT, McMahan CA, Tracy RE, Newman WP 3rd, Herderick EE, Cornhill JF. Prevalence and extent of atherosclerosis in adolescents and young adults: implications for prevention from the Pathobiological Determinants of Atherosclerosis in Youth Study. JAMA. 1999 Feb 24;281(8):727-35. doi: 10.1001/jama.281.8.727.
- Background: PubMed 12477941Yamada Y, Izawa H, Ichihara S, Takatsu F, Ishihara H, Hirayama H, Sone T, Tanaka M, Yokota M. Prediction of the risk of myocardial infarction from polymorphisms in candidate genes. N Engl J Med. 2002 Dec 12;347(24):1916-23. doi: 10.1056/NEJMoa021445.
Related trials for Arteriosclerosis
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
Myocardial Bridging, Coronary Atherosclerosis
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.
Barbara Biedermann, MD principal investigator
Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriosclerosis and Atherosclerosis, run by Kantonsspital Baselland Bruderholz.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Mar 2009. 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?
Results are not available in the source record.
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?
Cardiovascular events (time frame: 10 years at least). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863967, which also lists 9 linked publications.
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 18 Mar 2009.