Genetical, Anthropometrical and Biochemical Factors Influencing High Risk Subclinical Atherosclerosis

NCT02487615 | Completed

• 1 other identifier: 3852
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 2

Brief Summary

Subclinical atherosclerosis is the atherosclerotic process identified before clinical symptoms and thus it can be a useful marker of future cardiovascular events. It can be evaluated by many methods. This study included the diagnosis of subclincal atherosclerosis by four different methods: coronary calcium score, carotid doppler ultrasound to quantify intima media thickness and carotid plaques, exercise stress test and ankle brachial index. Clinical data, anthropometric measures (body mass index, abdominal circumference), markers of inflammation (high sensitive - C reactive protein, TNF alfa and Lipoprotein Associated Phospholipase A2), fat tissue function (leptin, resistin and adiponectin), glucose metabolism (fasting plasma glucose, glycated hemoglobin and insulin) and genetics markers of atherosclerotic process were evaluated as biomarkers of subclinical atherosclerosis in a uneventful population.

Conditions

Primary Prevention

Keywords

Glycaemia; Subclinical Atherosclerosis; Carotid Doppler Ultrasound; Carotid Plaque; Intima Media Thickness; Ankle Brachial Index; Exercise Stress Test; Coronary Calcium Score; Insulinemia; Leptin; Inflammation; Resistin; Tumor Necrosis Factor alpha; Phospholipase A2, Group VII; Body Mass Index; Adipose Tissue Function; Single Gene Polymorphism

Outcome Measures

Primary Outcomes (1)

• Carotid intima-media thickness (cIMT)

  Subclinical atherosclerosis evaluation by quantifying intima media thickness by Doppler

  Four Weeks

Secondary Outcomes (5)

• Coronary artery calcium score

  Four weeks

• Brachial Ankle Index

  Four weeks

• Ischemia induced by exercise stress test

  Four weeks

• Adiponectin, resistin, leptin, tumor necrosis factor alpha (TNF-α), lipoprotein associated phospholipase A2 (Lp-PLA2)

  Four weeks

• Genotyping of DNA at the following rs2383206, rs10757274, rs10757278, rs1051931, rs16874954 and rs1799724 and RNA of PLA2G7 (2-ΔCT), TNF-α (2-ΔCT), LEP (2-ΔCT), LEPR (2-ΔCT)

  Four weeks

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive individuals attended at the outpatient clinic of Dyslipidemia and of Hypertension and Nephrology Medical Sections of Dante Pazzanese Institute of Cardiology, a cardiologic tertiary hospital in São Paulo - Brazil.

You may qualify if:

• Individuals free of clinical manifested arterial atherosclerotic disease

You may not qualify if:

• Uncontrolled hypothyroidism
• Use of hypoglycemic medications
• Liver failure
• Chronic kidney disease stage IV or V
• Heart failure NYHA stage III or IV
• HIV positive patients
• Withdrawal of informed consent

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead
• University of Campinas, Brazil: collaborator

Study Sites (2)

State University Of Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

Dante Pazzanese Institute of Cardiology

São Paulo, São Paulo, 04012-909, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Whole blood, DNA

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andriana Bertolami, MD, PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

• Andrei C Sposito, MD, PhD

  University of Campinas, Brazil

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adriana Bertolami

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: February 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

BR (2)