Clinical Intervention Study in the Primary Care Setting o... | NCT01089530

Studies
Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)

NCT01089530

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Completed

Last Update Posted

Mar 18, 2010Estimated

Enrollment

436

Phase

Not Applicable

Conditions

Cardiovascular Risk Factors

Interventions

Lifestyle intensive group

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Feb 10, 2010

First Submission Date that Met QC Criteria

Mar 17, 2010

First Posted Date

Mar 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2010

Last Update Posted Date

Mar 18, 2010Estimated

Name	Class
SCMFIC FAMILY DOCTORS CATALAN SOCIETY GRANT	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

436

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard care	No Intervention		Behavioral: Lifestyle intensive group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle intensive group	Behavioral	hipocaloric diet smoking cessation physical exercise	Standard care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels.		24 months

Secondary Outcomes

Measure	Description	Time Frame
To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors.		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ABS Florida Sud		L'Hospitalet Del Llobregat	Barcelona	08905	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22381072	Derived	Rodriguez Cristobal JJ, Alonso-Villaverde Grote C, Trave Mercade P, Perez Santos JM, Pena Sendra E, Munoz Lloret A, Fernandez Perez C, Bleda Fernandez D; EFAP group. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease. BMC Res Notes. 2012 Mar 1;5:126. doi: 10.1186/1756-0500-5-126.