Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)
This study has been completed.
Sponsor:
Jordi Gol i Gurina Foundation
Collaborator:
SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANT
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01089530
First received: February 10, 2010
Last updated: March 17, 2010
Last verified: March 2010
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Purpose
Objectives:
- To study the possible effects of an intensive lifestyle change program on, the plasma fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and normal cholesterol levels, and moderate Cardiovascular Risk (CVR).
- To analyse whether or not the effect on fibrinogen is independent of the effect on lipids.
Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with no cardiovascular disease, with a high plasma fibrinogen (> 300 mg/dl) and a plasma cholesterol < 250 mg/dl, 218 received a more frequent and intensive intervention, consisting of advice on lifestyle changes and treatment. The follow up frequency of the intervention group was every two months. The other 218 patients continued with their usual care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.
| Condition | Intervention |
|---|---|
|
Cardiovascular Risk Factors |
Behavioral: Lifestyle intensive group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease |
Resource links provided by NLM:
Further study details as provided by Jordi Gol i Gurina Foundation:
Primary Outcome Measures:
- To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 436 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Standard care |
Behavioral: Lifestyle intensive group
hipocaloric diet smoking cessation physical exercise
|
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged between 30 and 75 years, than in 2 analytical consecutive, separated by a minimum interval of 15 days, have fibrinogen plasma > 300 mg/dl and plasma Total cholesterol < 250 mg/dl.
- Acceptance through informed consent of the patient to participate in the study.
Exclusion Criteria:
- Patients receiving lipid lowering treatment (including dietary measures)
- Local or generalized, acute or chronic infection.
- Patients with a history of cardiovascular disease.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jordi Gol i Gurina, IDIAP |
| ClinicalTrials.gov Identifier: | NCT01089530 History of Changes |
| Other Study ID Numbers: | P03/07 |
| Study First Received: | February 10, 2010 |
| Last Updated: | March 17, 2010 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Jordi Gol i Gurina Foundation:
|
Fibrinogen Cholesterol Cardiovascular risk factors |
Primary prevention High levels fibrinogen High plasma fibrinogen |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013