Peripheral Arterial DiseasePhase 4NCT00144937
Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease
A Phase 4 study testing Stepwise therapy for dyslipidemia, hypertension and diabetes, Dietary recommendations and Increase in physical activity in people with Peripheral Arterial Disease and Hypercholesterolemia, run by Hospital de Sabadell at 1 site in Spain.
Trial summary
The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without diabetes mellitus), can improve the control of these factors (mainly hypercholesterolemia and hypertension) in relation… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Hypercholesterolemia, Hypertension
- What is being tested?
- Stepwise therapy for dyslipidemia, hypertension and diabetes, Dietary recommendations and Increase in physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2003to Aug 2005
- Phase
- Phase 4
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arm-ankle index < 0.85 and > 0.40 in at least one leg
Who cannot join
- Advanced peripheral arterial disease (arm-ankle index < 0.40 or amputation)
- Peripheral arterial disease of non-atherosclerotic origin (e.g. vasculitis)
- Heart failure (NYHA III or IV)
- End-stage renal disease
- Atrial fibrillation
- Active peptic ulcer disease
Show all 13Show fewer
- Blood coagulation disorders
- Platelets disorders
- Cancer
- History of rhabdomyolysis
- Treatment with immunosuppressant agents (e.g. cyclosporine, glucocorticoids)
- Excessive intake of alcohol (> 280 gr/week)
- Institutionalized patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Usual Care With a Multifactorial Intensified Intervention on Cardiovascular Risk Factors in Subjects With Arterial Peripheral Disease With and Without Diabetes. The Taulí Intervention Program (TIP).
The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without diabetes mellitus), can improve the control of these factors (mainly hypercholesterolemia and hypertension) in relation to the habitual care
Read the detailed description
Subjects with peripheral arterial disease show an increased cardiovascular risk. It is thought that improving control of cardiovascular risk factors (hypercholesterolemia, hypertension, diabetes, smoking) could be beneficial in reducing their cardiovascular risk. However, usual care of these subjects (mainly at primary care) is not associated with an optimal control of such cardiovascular risk factors. We hypothesise that an intensive multifactorial treatment in a Cardiovascular Risk Unit could improve control of these cardiovascular risk factors. To test this hypothesis we perform a controlled, randomized, open, parallel trial. Subjects are recruited at the Vascular Surgery Unit and are randomised into two groups: 1. usual care (control group); 2. intensive care (intervention group). Randomization is stratified for the presence/absence of diabetes mellitus and with the use of sealed envelopes. Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo intensive multifactorial intervention. This intervention involves strict treatment goals (LDL-cholesterol < 100 mg/dl, blood pressure < 130/80, HbA1c < 7 %, no smoking) to be achieved through behavior modification (diet, physical activity, smoking cessation) and a stepwise introduction of pharmacologic therapy for hypercholesterolemia, hypertension and diabetes. This multifactorial intervention is overseen by a multidisciplinary team (endocrinologist, nurse, and dietitian) at the Hospital of Sabadell (Corporación Parc Taulí). The treatment goals are the same for the usual care group and general practitioners caring patients included in this study are informed of these strict treatment goals. Patients in the intensive-therapy receive 6 scheduled individual consultations in one year (baseline and 2,4, 6 and 9 months after their inclusion).Primary and secondary outcomes are evaluated at 12 months after their inclusion.
- Conditions
- Peripheral Arterial Disease, Hypercholesterolemia, Hypertension, Diabetes Mellitus, Smoking
- Being tested
- Stepwise therapy for dyslipidemia, hypertension and diabetes, Dietary recommendations, Increase in physical activity, Smoking cessation
- Medical subject headings
- Peripheral Arterial Disease, Hypercholesterolemia, Hypertension, Diabetes Mellitus, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise therapy for dyslipidemia, hypertension and diabetesDrug
Dietary recommendationsBehavioural
Increase in physical activityBehavioural
Smoking cessationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months)
Secondary outcomes (17)
Decrease in basal glycaemia and HbA1c(only subjects with diabetes)
Lowering of serum triglycerides and total cholesterol.
Increase in serum HDL cholesterol
Improvement in cardiovascular risk (Framingham Score and UKPDS engine)
Weight reduction
Increase in physical activity
Changes in dietary intake
Smoking cessation
Improvement in health-related quality of life (SF-36)
Improvement of intermittent claudication
Improvement of arm-ankle index
Effect of control of cardiovascular risk factors on metabolic and inflammatory markers associated with cardiovascular disease
Changes in serum concentrations of hepatic enzymes
Changes in use of statins and fibrates
Changes in use of antihypertensive drugs and hypoglycemic agents
Cardiovascular events
All the above-mentioned primary and secondary outcomes will be evaluated at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMar 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Hospital de Sabadell
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- José-Miguel González-Clemente, MD, PhD, Principal investigator, Department of Diabetes, Endocrinology and Nutrition. Hospital de SabadellDídac Mauricio, MD, PhD, Study chair, Department of Diabetes, Endocrinology and Metabolism. Hospital de Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144937
- Sponsor's protocol ID
- 2003020
- Status last verified
- Sep 2005
- First submitted
- 1 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Usual Care With a Multifactorial Intensified Intervention on Cardiovascular Risk Factors in Subjects With Arterial Peripheral Disease With and Without Diabetes. The Taulí Intervention Program (TIP).
- ClinicalTrials.gov ID
- NCT00144937
- Acronym / sponsor ID
- 2003020
- Conditions
- Peripheral Arterial Disease, Hypercholesterolemia, Hypertension, Diabetes Mellitus, Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Hospital de SabadellUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2003
- Study completion
- Aug 2005
- First posted
- 5 Sep 2005 (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.
The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without diabetes mellitus), can improve the control of these factors (mainly hypercholesterolemia and hypertension) in relation to the habitual care
Detailed description
Subjects with peripheral arterial disease show an increased cardiovascular risk. It is thought that improving control of cardiovascular risk factors (hypercholesterolemia, hypertension, diabetes, smoking) could be beneficial in reducing their cardiovascular risk. However, usual care of these subjects (mainly at primary care) is not associated with an optimal control of such cardiovascular risk factors. We hypothesise that an intensive multifactorial treatment in a Cardiovascular Risk Unit could improve control of these cardiovascular risk factors. To test this hypothesis we perform a controlled, randomized, open, parallel trial. Subjects are recruited at the Vascular Surgery Unit and are randomised into two groups: 1. usual care (control group); 2. intensive care (intervention group). Randomization is stratified for the presence/absence of diabetes mellitus and with the use of sealed envelopes. Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo intensive multifactorial intervention. This intervention involves strict treatment goals (LDL-cholesterol < 100 mg/dl, blood pressure < 130/80, HbA1c < 7 %, no smoking) to be achieved through behavior modification (diet, physical activity, smoking cessation) and a stepwise introduction of pharmacologic therapy for hypercholesterolemia, hypertension and diabetes. This multifactorial intervention is overseen by a multidisciplinary team (endocrinologist, nurse, and dietitian) at the Hospital of Sabadell (Corporación Parc Taulí). The treatment goals are the same for the usual care group and general practitioners caring patients included in this study are informed of these strict treatment goals. Patients in the intensive-therapy receive 6 scheduled individual consultations in one year (baseline and 2,4, 6 and 9 months after their inclusion).Primary and secondary outcomes are evaluated at 12 months after their inclusion.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Arm-ankle index < 0.85 and > 0.40 in at least one leg
Key exclusion criteria (13 listed)
- Advanced peripheral arterial disease (arm-ankle index < 0.40 or amputation)
- Peripheral arterial disease of non-atherosclerotic origin (e.g. vasculitis)
- Heart failure (NYHA III or IV)
- End-stage renal disease
- Atrial fibrillation
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 |
|---|---|---|
| Stepwise therapy for dyslipidemia, hypertension and diabetes | Drug | – |
| Dietary recommendations | Behavioural | – |
| Increase in physical activity | Behavioural | – |
| Smoking cessation | Behavioural | – |
Primary outcome
Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months)
17 secondary outcomes
Decrease in basal glycaemia and HbA1c(only subjects with diabetes)
Lowering of serum triglycerides and total cholesterol.
Increase in serum HDL cholesterol
Improvement in cardiovascular risk (Framingham Score and UKPDS engine)
Weight reduction
Increase in physical activity
Changes in dietary intake
Smoking cessation
Improvement in health-related quality of life (SF-36)
Improvement of intermittent claudication
Improvement of arm-ankle index
Effect of control of cardiovascular risk factors on metabolic and inflammatory markers associated with cardiovascular disease
Changes in serum concentrations of hepatic enzymes
Changes in use of statins and fibrates
Changes in use of antihypertensive drugs and hypoglycemic agents
Cardiovascular events
All the above-mentioned primary and secondary outcomes will be evaluated at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2005.
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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.
José-Miguel González-Clemente, MD, PhD principal investigator
Department of Diabetes, Endocrinology and Nutrition. Hospital de Sabadell
Dídac Mauricio, MD, PhD study chair
Department of Diabetes, Endocrinology and Metabolism. Hospital de Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stepwise therapy for dyslipidemia, hypertension and diabetes, Dietary recommendations and Increase in physical activity in people with Peripheral Arterial Disease and Hypercholesterolemia, run by Hospital de Sabadell 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 1 inclusion and 13 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 5 Sep 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lowering of LDL cholesterol concentrations and blood pressure levels (at 12 months). Increase in use of antiplatelet agents (at 12 months). 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 5 Sep 2005.