Vastmanland Myocardial Infarction Study (VaMIS)

This study has been completed.
Sponsor:
Collaborator:
Västmanland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01452178
First received: October 11, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted

October 11, 2011
October 11, 2011
November 2005
May 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Type D personality as measured from the type D Scale-14 (DS14) questionnaire.
  • Cardiovascular events - longitudinal outcome measure. [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]
    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.
Same as current
No Changes Posted
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Vastmanland Myocardial Infarction Study (VaMIS)
Observational Study on Peripheral Vascular Disease, Glucometabolic Status, and Type D Personality in Patients With Acute Myocardial Infarction.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Whole blood and serum.

Probability Sample

Consecutive patients hospitalized for acute myocardial infarction. Control subjects, matched to the patients for age, sex, and municipality, were randomly selected from the general population.

  • Acute Myocardial Infarction
  • Peripheral Artery Disease
  • Diabetes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1008
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized at the Department of Cardiology, Central Hospital, Västerås, Sweden.
  • Living in the catchment area of the Central Hospital, Västerås, Sweden.
  • Diagnosis of acute myocardial infarction, i.e. a rise in serum concentration of troponin-I to >= 0.4 microgram/Liter and its subsequent fall in combination with one of the following: a) ischaemic symptoms, b) development of Q-waves on the ECG, c) ECG-changes indicative o ischaemia (ST segment elevation or depression), or d) coronary artery intervention.

Exclusion Criteria:

  • age less than 18 years
  • severly impaired communication capabilities
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01452178
VaMIS
Yes
Uppsala University
Uppsala University
Västmanland County Council, Sweden
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
Uppsala University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP