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Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis (HMS-02)

This study is currently recruiting participants.
Verified May 2010 by Central Hospital of Kanta-Hame
Sponsor:
Collaborators:
Linnan Klinikka, Hämeenlinna, Finland
Mehiläinen Hämeenlinna, Finland
Finnish Red Cross Blood Transfusion Service
Information provided by:
Central Hospital of Kanta-Hame
ClinicalTrials.gov Identifier:
NCT01119404
First received: May 6, 2010
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  Purpose

Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart disease and 80 physically active controls and in different settings.


Condition
Metabolic Syndrome
Coronary Heart Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Hämeenlinna Metabolic Syndrome Research Program (HMS): Surrogate Indicators for Atherosclerosis in Men With Metabolic Syndrome, Coronary Heart Disease and Controls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central Hospital of Kanta-Hame:

Biospecimen Retention:   Samples Without DNA

serum, EDTA plasma, citrate plasma


Estimated Enrollment: 300
Study Start Date: June 2003
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Metabolic Syndrome
120 men with metabolic syndrome
Coronary Heart Disease (CHD)
120 men with angiographically verified CHD
Control
80 physically active men

Detailed Description:

Accumulation of oxidized low-density lipoproteins (LDL) in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease.

In this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control).

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Group 1: Metabolic syndrome

  • 120 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III
  • MetS diagnosed in routine health examination and laboratory tests
  • Age: 30 to 65 years

Group 2: Coronary heart disease (CHD)

  • 120 Finnish men with angiographically proven CHD
  • Age: 30 to 65 years

Group 3: Control

  • 80 Finnish men
  • Exercising physically more than three times a week and more than 30 minutes per exercise on regular basis
  • Never been studied or treated because of cardiovascular disease
  • Age: 30 to 65 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119404

Contacts
Contact: Ari K Palomäki, MD PhD +35836294540 ari.palomaki@khshp.fi
Contact: Kalevi Oksanen, MD PhD +35836292369 kalevi.oksanen@khshp.fi

Locations
Finland
Finnish Red Cross Blood Transfusion Service Completed
Helsinki, Finland, 00310
Central Hospital of Kanta-Häme Recruiting
Hämeenlinna, Finland, 13530
Contact: Ari K Palomäki, MD PhD     +35836294540     ari.palomaki@khshp.fi    
Contact: Kalevi Oksanen, MD PhD     +35836292369     kalevi.oksanen@khshp.fi    
Sub-Investigator: Hanna P Pohjantähti-Maaroos, MD            
Sub-Investigator: Sari Husgafvel, MSc            
Sub-Investigator: Päivi Kankkunen, MSc            
Principal Investigator: Ari K Palomäki, MD PhD            
Principal Investigator: Kalevi Oksanen, MD PhD            
Linnan Klinikka Completed
Hämeenlinna, Finland, 13100
Mehiläinen Hämeenlinna Completed
Hämeenlinna, Finland, 13100
Sponsors and Collaborators
Central Hospital of Kanta-Hame
Linnan Klinikka, Hämeenlinna, Finland
Mehiläinen Hämeenlinna, Finland
Finnish Red Cross Blood Transfusion Service
Investigators
Study Director: Ari K Palomäki, MD PhD Central Hospital of Kanta-Häme
Study Director: Kalevi Oksanen, MD PhD Central Hospital of Kanta-Häme
  More Information

No publications provided by Central Hospital of Kanta-Hame

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ari Palomäki, MD PhD, Central Hospital of Kanta-Häme
ClinicalTrials.gov Identifier: NCT01119404     History of Changes
Other Study ID Numbers: KHMetS-02-AP, HMS-02
Study First Received: May 6, 2010
Last Updated: May 10, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by Central Hospital of Kanta-Hame:
Metabolic Syndrome
Coronary Heart Disease
Erectile Dysfunction
Arterial Elasticity
Oxidized Low Density Lipoprotein
Cardiovascular Diseases
 Risk Assessment
Endothelial Dysfunction
Diabetes Mellitus
Surrogate Markers
Risk Factors

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Metabolic Syndrome X
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013