Osteoarthritis Cardiovascular Risk Factors

February 9, 2014 updated by: Joan Calvet Fontova, Hospital Parc Taulí, Sabadell

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Parc Tauli Sabadell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients referred for symptomatic hand or knee osteoarthritis
  • All patients referred in the same period for soft tissue disease
  • > 50 years old

Exclusion Criteria:

  • Any other rheumatologic condition
  • secondary osteoarthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Knee osteoarthritis
Patients over 50 years who presented to an outpatient rheumatology for 1 year and who had knee osteoarthritis.
Other: 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: History of cardiovascular disease
In all patient we collect the history of cardiovascular disease.
Other: Cardiovascular risk factors association
We have defined two groups according to grouping of none, 1 or 2 cardiovascular risk factors or 3 or more.
Hand osteoarthritis
Patients over 50 years who presented to an outpatient rheumatology for 1 year and who had hand osteoarthritis.
Other: 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: History of cardiovascular disease
In all patient we collect the history of cardiovascular disease.
Other: Cardiovascular risk factors association
We have defined two groups according to grouping of none, 1 or 2 cardiovascular risk factors or 3 or more.
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.
Other: 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: History of cardiovascular disease
In all patient we collect the history of cardiovascular disease.
Other: Cardiovascular risk factors association
We have defined two groups according to grouping of none, 1 or 2 cardiovascular risk factors or 3 or more.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of cardiovascular disease in hand or knee osteoarthritis.
Time Frame: one month
We evaluate the prevalence of cardiovascular disease in the three cohorts, hand osteoarthritis, knee osteoarthritis and soft tissue disease; and we compare them.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Parc Taulí, Sabadell

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: jordi Gratacos, MD Ph, Hospital Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Joan02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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