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Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.

Information source: Hospital Arnau de Vilanova
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atherosclerosis; Cardiovascular Diseases

Intervention: Simvastatin or Atorvastatin (Drug); Enalapril (Drug); Aspirin or clopidogrel (Drug); Rimonabant (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital Arnau de Vilanova

Official(s) and/or principal investigator(s):
Elvira Fernandez, MD,PhD, Principal Investigator, Affiliation: Hospital Arnau de Vilanova

Overall contact:
Blai Coll, MD,PhD, Phone: +34 619633249, Email: bcoll@arnau.scs.es

Summary

The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.

Clinical Details

Official title: Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Carotid Intima-Media Thickness progression/regression

Secondary outcome: Cardio and cerebrovascular eventS

Detailed description: We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk. With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.

Eligibility

Minimum age: 40 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

Inclusion Criteria One or more of the following:

- Familiar History of early-onset cardiovascular disease (male < 55 or female < 65).

- Type 2 Diabetes mellitus or type 1 with microalbuminuria.

- Essential High Blood Pressure.

- Chronic Kidney Disease.

- Primary hyperlipidemia.

The presence of two or more of the following:

- Current smoker.

- Physical inactivity.

- High blood pressure (recently diagnosed).

- Abdominal perimeter: > 102 cm. males; > 88 cm. females.

- Total cholesterol > 240 mg/dL.

- HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females.

Exclusion Criteria:

- Age < 40 or > 74 years old.

- Previous Cardiovascular Event.

Locations and Contacts

Blai Coll, MD,PhD, Phone: +34 619633249, Email: bcoll@arnau.scs.es

Hospital Arnau de Vilanova, Lleida, Catalunya 25260, Spain; Recruiting
Blai Coll, MD,PhD, Phone: +34 619633249, Email: bcoll@arnau.scs.es
Blai Coll, MD,PhD, Sub-Investigator
Merce Borras, MD,PhD, Sub-Investigator
Additional Information

Starting date: April 2008
Last updated: August 13, 2008

Page last updated: August 23, 2015

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