OsteoarthritisNCT01902654
Osteoarthritis Cardiovascular Risk Factors
An observational study of Osteoarthritis and Cardiovascular Risk Factors, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial summary
We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Cardiovascular Risk Factors, Cardiovascular Disease
- What is being tested?
- Cardiovascular risk factors diagnoses collection., History of cardiovascular disease and Cardiovascular risk factors association
- How many people
- 490 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Feb 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the rheumatology outpatient for symptomatic hand or knee osteoarthritis or soft tissue disease. Patients were referred by their primary care physician, and all patients were visited in primary care assitance.
Who may be able to join
- Patients referred for symptomatic hand or knee osteoarthritis
- All patients referred in the same period for soft tissue disease
- > 50 years old
Who cannot join
- Any other rheumatologic condition
- secondary osteoarthritis
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Parc Tauli Sabadell
Sabadell, Barcelona, 08208
Joan Calvet, Dr, 0034937231010 ext. 24065, joan.calvet.fontova@gmail.com
Orellana Cristobal, Dr, 0034937231010 ext. 24065, corellana@tauli.cat
About this study
Official title: Prevalence of Cardiovascular Risk Factors Between Patients With Knee or Hand Osteoarthritis
We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.
- Being tested
- Cardiovascular risk factors diagnoses collection., History of cardiovascular disease, Cardiovascular risk factors association
- Keywords
- Osteoarthritis, cardiovascular disease
- Medical subject headings
- Osteoarthritis, Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular risk factors diagnoses collection.Other
We look over patient medical record and we collect the diagnoses associated with cardiovascular risk factor as hypertension, obesity, dislipidemia and diabetes.
History of cardiovascular diseaseOther
In all patient we collect the history of cardiovascular disease.
Cardiovascular risk factors associationOther
We have defined two groups according to grouping of none, 1 or 2 cardiovascular risk factors or 3 or more.
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis | Patients over 50 years who presented to an outpatient rheumatology for 1 year and who had knee osteoarthritis. Receives: Other: Cardiovascular risk factors diagnoses collection.; Other: History of cardiovascular disease; Other: Cardiovascular risk factors association | |
| Hand osteoarthritis | Patients over 50 years who presented to an outpatient rheumatology for 1 year and who had hand osteoarthritis. Receives: Other: Cardiovascular risk factors diagnoses collection.; Other: History of cardiovascular disease; Other: Cardiovascular risk factors association | |
| Soft tissue disease | All patients over 50 years who presented during the same period of time of other cohorts, to an outpatient rheumatology and who had soft tissue disease with no other rheumatic condition. Receives: Other: Cardiovascular risk factors diagnoses collection.; Other: History of cardiovascular disease; Other: Cardiovascular risk factors association |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiovascular risk factors in hand or knee osteoarthritis patients
We analyze the prevalence of cardiovascular risk factors in a cohort of knne osteoarthritis and in a cohort of hand osteoarthritis. Then we evaluate the prevalence of cardiovascular risk factors in a cohort of soft tissue disease patients. Finally we compare osteoarthritis patients with soft tissue disease patients.
Measured: one month
Secondary outcomes (1)
Prevalence of cardiovascular disease in hand or knee osteoarthritis.
We evaluate the prevalence of cardiovascular disease in the three cohorts, hand osteoarthritis, knee osteoarthritis and soft tissue disease; and we compare them.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Retrospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Calvet Fontova, Parc Taulí Hospital Universitari
- Investigators
- jordi Gratacos, MD Ph, Study director, Hospital Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902654
- Sponsor's protocol ID
- Joan02
- Status last verified
- Nov 2013
- First submitted
- 9 Jul 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiovascular Risk Factors Between Patients With Knee or Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT01902654
- Acronym / sponsor ID
- Joan02
- Keywords
- Osteoarthritis, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (estimated)
- First posted
- 18 Jul 2013 (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.
We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis | – | Other: Cardiovascular risk factors diagnoses collection., Other: History of cardiovascular disease, Other: Cardiovascular risk factors associationPatients over 50 years who presented to an outpatient rheumatology for 1 year and who had knee osteoarthritis. |
| Hand osteoarthritis | – | Other: Cardiovascular risk factors diagnoses collection., Other: History of cardiovascular disease, Other: Cardiovascular risk factors associationPatients over 50 years who presented to an outpatient rheumatology for 1 year and who had hand osteoarthritis. |
| Soft tissue disease | – | Other: Cardiovascular risk factors diagnoses collection., Other: History of cardiovascular disease, Other: Cardiovascular risk factors associationAll patients over 50 years who presented during the same period of time of other cohorts, to an outpatient rheumatology and who had soft tissue disease with no other rheumatic condition. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the rheumatology outpatient for symptomatic hand or knee osteoarthritis or soft tissue disease. Patients were referred by their primary care physician, and all patients were visited in primary care assitance.
Key inclusion criteria (3 listed)
- Patients referred for symptomatic hand or knee osteoarthritis
- All patients referred in the same period for soft tissue disease
- > 50 years old
Key exclusion criteria (2 listed)
- Any other rheumatologic condition
- secondary osteoarthritis
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 |
|---|---|---|
| Cardiovascular risk factors diagnoses collection.We look over patient medical record and we collect the diagnoses associated with cardiovascular risk factor as hypertension, obesity, dislipidemia and diabetes. | Other | Hand osteoarthritis, Knee osteoarthritis, Soft tissue disease |
| History of cardiovascular diseaseIn all patient we collect the history of cardiovascular disease. | Other | Hand osteoarthritis, Knee osteoarthritis, Soft tissue disease |
| Cardiovascular risk factors associationWe have defined two groups according to grouping of none, 1 or 2 cardiovascular risk factors or 3 or more. | Other | Hand osteoarthritis, Knee osteoarthritis, Soft tissue disease |
Primary outcome
Prevalence of cardiovascular risk factors in hand or knee osteoarthritis patients
Time frame: one month
We analyze the prevalence of cardiovascular risk factors in a cohort of knne osteoarthritis and in a cohort of hand osteoarthritis. Then we evaluate the prevalence of cardiovascular risk factors in a cohort of soft tissue disease patients. Finally we compare osteoarthritis patients with soft tissue disease patients.
1 secondary outcome
Prevalence of cardiovascular disease in hand or knee osteoarthritis.
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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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.
jordi Gratacos, MD Ph study director
Hospital Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Cardiovascular Risk Factors, run by Parc Taulí Hospital Universitari at 1 site in Spain.
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 3 inclusion and 2 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 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Joan Calvet, Dr (0034 937231010 ext. 24065, joan.calvet.fontova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cardiovascular risk factors in hand or knee osteoarthritis patients (time frame: one month). 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 11 Feb 2014.