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NCT Number: NCT01452178

Vastmanland Myocardial Infarction Study (VaMIS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Clinical Research, Uppsala University, Västmanland County Hospital

Västerås, SE-72189, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Prevalence of type D personality - cross sectional measure.

    Time frame: baseline

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

  4. 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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Västmanland County Council, Sweden

Registry information

Official study title

Observational Study on Peripheral Vascular Disease, Glucometabolic Status, and Type D Personality in Patients With Acute Myocardial Infarction.

Acronym: VaMIS

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2011
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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