Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144937
Status:
UNKNOWN
Last Update Posted:
2005-09-05
First Post:
2005-09-01
Brief Title:
Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease
Sponsor:
Hospital de Sabadell
Organization:
Hospital de Sabadell
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 presenceabsence 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 mgdl blood pressure 13080 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 24 6 and 9 months after their inclusionPrimary and secondary outcomes are evaluated at 12 months after their inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None