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
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