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
  Purpose

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
Acute Myocardial Infarction
Peripheral Artery Disease
Diabetes

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Whole blood and serum.


Enrollment: 1008
Study Start Date: November 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452178

Locations
Sweden
Center of Clinical Research, Uppsala university, Central Hospital
Västerås, Sweden, SE-72189
Sponsors and Collaborators
Uppsala University
Västmanland County Council, Sweden
Investigators
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
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01452178     History of Changes
Other Study ID Numbers: VaMIS
Study First Received: October 11, 2011
Last Updated: October 11, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board

Keywords provided by Uppsala University:
Cardiovascular diseases
Glucometabolic disorders
Type-D personality

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Peripheral Vascular Diseases
Peripheral Arterial Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 19, 2014