Vastmanland Myocardial Infarction Study (VaMIS) (VaMIS)
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|ClinicalTrials.gov Identifier: NCT01452178|
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : October 14, 2011
The main purposes of this study are:
- to describe the prevalence of peripheral artery disease (including lower extremity artery disease, carotid artery disease, renal artery disease, and abdominal aortic disease) in patients with acute myocardial infarction in comparison to control subject from the general population,
- to evaluate the association of peripheral artery disease with glucometabolic status in patients with acute myocardial infarction,
- to assess the prevalence of type D personality in patients with acute myocardial infarction com pared to control subjects from the general population,
- to examine the prognostic value of peripheral artery disease in patients with acute myocardial infartion, and
- to evaluate the prognostic value of type D personality in patients with acute myocardial infarction.
|Condition or disease|
|Acute Myocardial Infarction Peripheral Artery Disease Diabetes|
Atherosclerotic arterial disease is the main cause of premature death worldwide and is anticipated to remain the single leading cause of morbidity and mortality the following two decades. Coronary heart disease (CHD) and peripheral arterial disease (PAD) are important clinical manifestation of atherosclerosis which have common underlying arterial pathology, risk factors, and preventive treatments, but they are not often studied concurrently. In the view of secondary prevention we need to know more about the prevalence of cardiovascular disease and prognosis in patients at documented high risk, i.e. patients with manifested CHD. Previous studies on patients with CHD and concomitant PAD have focused mainly on either lower extremity PAD or carotid artery disease. In this project we expand the concept of PAD in patients with CHD to include lower extremity arterial disease, carotid artery disease, renal artery disease, and abdominal aortic aneurysmal disease.
Diabetes mellitus is a well recognised risk factor for cardiovascular morbidity and mortality. However, even prediabetic conditions carry an increased risk. One possible explanation for this increased risk may be the presence of a greater number of atherosclerotic lesions in patients with glucometabolic disorders than in patients without such disorders. We aim to evaluate the association of PAD with glucometabolic status in patients with manifest CHD.
A growing body of research has demonstrated the role of psychosocial and behavioural risk factors in the pathogenesis and prognosis of cardiovascular disorders. Recently, the type D ("distressed") personality construct has been proposed as a strong risk factor for cardiovascular morbidity and mortality. Type D personality is characterized by high levels of two personality traits: negative affectivity (e.g. worry, irritability, and gloom) and social inhibition (e.g. lack of self-assurance and reticence). The data on type D personality as a risk factor for cardiovascular disease has been limited to few research groups and there is a need to replicate those data in other populations.
|Study Type :||Observational|
|Actual Enrollment :||1008 participants|
|Official Title:||Observational Study on Peripheral Vascular Disease, Glucometabolic Status, and Type D Personality in Patients With Acute Myocardial Infarction.|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
- Prevalence of peripheral artery disease (lower extremity artery disease, carotid artery disease, renal artery disease, or abdominal aortic aneurysm) - cross sectional outcome measure. [ Time Frame: baseline ]Peripheral artery disease as diagnosed by blood pressure measurements in ankles and arms (ankle-brachial-index) for lower extremity artery disease, or as diagnosed by ultrasonography for carotid artery disease, renal artery disease, or abdominal aortic aneurysm.
- Prevalence of glucometabolic disorders - cross sectional outcome measure. [ Time Frame: basline ]Known diabetes (from medical records), newly diagnosed diabetes, and impaired glucose tolerance (as diagnosed from plasma glucose levels and/or an oral glucose tolerance test.
- Prevalence of type D personality - cross sectional measure. [ Time Frame: baseline ]Type D personality as measured from the type D Scale-14 (DS14) questionnaire.
- Cardiovascular events - longitudinal outcome measure. [ Time Frame: 5-10 years ]Cardiovascular events obtained from the Swedish National Causes of Death register and the Swedish National In-Patient register. The registers are linked to the patients by the unique personal identification number assigned to each swedish resident.
Biospecimen Retention: Samples With DNA
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): NCT01452178
|Center of Clinical Research, Uppsala university, Central Hospital|
|Västerås, Sweden, SE-72189|
|Study Chair:||Jerzy Leppert, Professor||Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden|
|Principal Investigator:||Göran Nilsson, Professor||Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden|
|Principal Investigator:||Pär Hedberg, MD, PhD||Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden|