Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis (HMS-02)
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ClinicalTrials.gov Identifier: NCT01119404 |
Recruitment Status
: Unknown
Verified May 2010 by Central Hospital of Kanta-Hame.
Recruitment status was: Recruiting
First Posted
: May 7, 2010
Last Update Posted
: May 11, 2010
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Condition or disease |
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Metabolic Syndrome Coronary Heart Disease |
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).
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
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 |
Study Start Date : | June 2003 |
Estimated Primary Completion Date : | June 2014 |
Estimated Study Completion Date : | December 2014 |

Group/Cohort |
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Metabolic Syndrome
120 men with metabolic syndrome
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Coronary Heart Disease (CHD)
120 men with angiographically verified CHD
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Control
80 physically active men
|

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Ages Eligible for Study: | 30 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119404
Contact: Ari K Palomäki, MD PhD | +35836294540 | ari.palomaki@khshp.fi | |
Contact: Kalevi Oksanen, MD PhD | +35836292369 | kalevi.oksanen@khshp.fi |
Finland | |
Finnish Red Cross Blood Transfusion Service | Completed |
Helsinki, Finland, 00310 | |
Linnan Klinikka | Completed |
Hämeenlinna, Finland, 13100 | |
Mehiläinen Hämeenlinna | Completed |
Hämeenlinna, Finland, 13100 | |
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 |
Study Director: | Ari K Palomäki, MD PhD | Central Hospital of Kanta-Häme | |
Study Director: | Kalevi Oksanen, MD PhD | Central Hospital of Kanta-Häme |
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 ( Other Identifier: Ethics Committee ) |
First Posted: | May 7, 2010 Key Record Dates |
Last Update Posted: | May 11, 2010 |
Last Verified: | May 2010 |
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:
Syndrome Heart Diseases Metabolic Syndrome X Atherosclerosis Coronary Disease Coronary Artery Disease Myocardial Ischemia Disease Pathologic Processes |
Cardiovascular Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |