Vastmanland Myocardial Infarction Study (VaMIS)

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT01452178
Collaborator
Västmanland County Council, Sweden (Other)
1,008
1
65.9
15.3

Study Details

Study Description

Brief Summary

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 Intervention/Treatment Phase

    Detailed Description

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1008 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Study on Peripheral Vascular Disease, Glucometabolic Status, and Type D Personality in Patients With Acute Myocardial Infarction.
    Study Start Date :
    Nov 1, 2005
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of peripheral artery disease (lower extremity artery disease, carotid artery disease, renal artery disease, or abdominal aortic aneurysm) - cross sectional outcome measure. [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.

    2. Prevalence of glucometabolic disorders - cross sectional outcome measure. [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.

    3. Prevalence of type D personality - cross sectional measure. [baseline]

      Type D personality as measured from the type D Scale-14 (DS14) questionnaire.

    4. Cardiovascular events - longitudinal outcome measure. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center of Clinical Research, Uppsala university, Central Hospital Västerås Sweden SE-72189

    Sponsors and Collaborators

    • Uppsala University
    • Västmanland County Council, Sweden

    Investigators

    • Study Chair: Pär Hedberg, Assoc. Professor, Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
    • Principal Investigator: Jerzy Leppert, Senior Professor, Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT01452178
    Other Study ID Numbers:
    • VaMIS
    First Posted:
    Oct 14, 2011
    Last Update Posted:
    May 8, 2020
    Last Verified:
    May 1, 2020

    Study Results

    No Results Posted as of May 8, 2020