Vastmanland Myocardial Infarction Study (VaMIS)

Diabetes Clinical Trial

— VaMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452178
• Other study ID #: VaMIS
• Status: Completed
• Start date: November 2005
• Est. completion date: May 2011

Study information

• Verified date: May 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Diabetes
• Infarction
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Sweden	Center for Clinical Research, Uppsala University, Västmanland County Hospital	Västerås

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Västmanland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (18)

Calais F, Eriksson Ostman M, Hedberg P, Rosenblad A, Leppert J, Frobert O. Incremental prognostic value of coronary and systemic atherosclerosis after myocardial infarction. Int J Cardiol. 2018 Jun 15;261:6-11. doi: 10.1016/j.ijcard.2018.02.035. — View Citation

Calais F, Frobert O, Rosenblad A, Hedberg PO, Wachtell K, Leppert J. Leisure-time physical inactivity and risk of myocardial infarction and all-cause mortality: a case-control study. Int J Cardiol. 2014 Dec 15;177(2):599-600. doi: 10.1016/j.ijcard.2014.08 — View Citation

Cederlof ET, Johnston N, Leppert J, Hedberg P, Lindahl B, Christersson C. Do self-reported pregnancy complications add to risk evaluation in older women with established cardiovascular disease? BMC Womens Health. 2019 Dec 16;19(1):160. doi: 10.1186/s12905 — View Citation

Conden E, Rosenblad A, Ekselius L, Aslund C. Prevalence of type D personality and factorial and temporal stability of the DS14 after myocardial infarction in a Swedish population. Scand J Psychol. 2014 Dec;55(6):601-10. doi: 10.1111/sjop.12162. Epub 2014 — View Citation

Conden E, Rosenblad A, Wagner P, Leppert J, Ekselius L, Aslund C. Is type D personality an independent risk factor for recurrent myocardial infarction or all-cause mortality in post-acute myocardial infarction patients? Eur J Prev Cardiol. 2017 Mar;24(5): — View Citation

Conden E, Rosenblad A. Insomnia predicts long-term all-cause mortality after acute myocardial infarction: A prospective cohort study. Int J Cardiol. 2016 Jul 15;215:217-22. doi: 10.1016/j.ijcard.2016.04.080. Epub 2016 Apr 15. — View Citation

Doerstling S, Hedberg P, Ohrvik J, Leppert J, Henriksen E. Growth differentiation factor 15 in a community-based sample: age-dependent reference limits and prognostic impact. Ups J Med Sci. 2018 Jun;123(2):86-93. doi: 10.1080/03009734.2018.1460427. Epub 2 — View Citation

Eriksson Ostman M, Calais F, Rosenblad A, Frobert O, Leppert J, Hedberg P. Prognostic impact of subclinical or manifest extracoronary artery diseases after acute myocardial infarction. Atherosclerosis. 2017 Aug;263:53-59. doi: 10.1016/j.atherosclerosis.20 — View Citation

Hedberg P, Selmeryd J, Leppert J, Henriksen E. Long-term prognostic impact of left atrial volumes and emptying fraction in a community-based cohort. Heart. 2017 May;103(9):687-693. doi: 10.1136/heartjnl-2016-310242. Epub 2016 Nov 9. — View Citation

Henriksen E, Selmeryd J, Hedberg P. Associations of left atrial volumes and Doppler filling indices with left atrial function in acute myocardial infarction. Clin Physiol Funct Imaging. 2019 Jan;39(1):85-92. doi: 10.1111/cpf.12533. Epub 2018 Jul 1. — View Citation

Lodder P, Wicherts JM, Antens M, Albus C, Bessonov IS, Conden E, Dulfer K, Gostoli S, Grande G, Hedberg P, Herrmann-Lingen C, Jaarsma T, Koo M, Lin P, Lin TK, Meyer T, Pushkarev G, Rafanelli C, Raykh OI, Schaan de Quadros A, Schmidt M, Sumin AN, Utens EMW — View Citation

Nilsson G, Hedberg P, Leppert J, Ohrvik J. Basic Anthropometric Measures in Acute Myocardial Infarction Patients and Individually Sex- and Age-Matched Controls from the General Population. J Obes. 2018 Oct 2;2018:3839482. doi: 10.1155/2018/3839482. eColle — View Citation

Nilsson G, Leppert J, Ohrvik J. Enigma of the cholesterol paradox in acute myocardial infarction: lessons from an 8-year follow-up of all-cause mortality in an age-matched and sex-matched case-control study with controls from the patients' recruitment are — View Citation

Nowak C, Carlsson AC, Ostgren CJ, Nystrom FH, Alam M, Feldreich T, Sundstrom J, Carrero JJ, Leppert J, Hedberg P, Henriksen E, Cordeiro AC, Giedraitis V, Lind L, Ingelsson E, Fall T, Arnlov J. Multiplex proteomics for prediction of major cardiovascular ev — View Citation

Selmeryd J, Henriksen E, Dalen H, Hedberg P. Derivation and Evaluation of Age-Specific Multivariate Reference Regions to Aid in Identification of Abnormal Filling Patterns: The HUNT and VaMIS Studies. JACC Cardiovasc Imaging. 2018 Mar;11(3):400-408. doi: — View Citation

Selmeryd J, Henriksen E, Leppert J, Hedberg P. Interstudy heterogeneity of definitions of diastolic dysfunction severely affects reported prevalence. Eur Heart J Cardiovasc Imaging. 2016 Aug;17(8):892-9. doi: 10.1093/ehjci/jev211. Epub 2015 Sep 15. — View Citation

Skau E, Henriksen E, Wagner P, Hedberg P, Siegbahn A, Leppert J. GDF-15 and TRAIL-R2 are powerful predictors of long-term mortality in patients with acute myocardial infarction. Eur J Prev Cardiol. 2017 Oct;24(15):1576-1583. doi: 10.1177/2047487317725017. — View Citation

Velders MA, Calais F, Dahle N, Fall T, Hagstrom E, Leppert J, Nowak C, Tenerz A, Arnlov J, Hedberg P. Cathepsin D improves the prediction of undetected diabetes in patients with myocardial infarction. Ups J Med Sci. 2019 Aug;124(3):187-192. doi: 10.1080/0 — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of peripheral artery disease (lower extremity artery disease, carotid artery disease, renal artery disease, or abdominal aortic aneurysm) - cross sectional outcome measure.	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.	baseline
Primary	Prevalence of glucometabolic disorders - cross sectional outcome measure.	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.	basline
Primary	Prevalence of type D personality - cross sectional measure.	Type D personality as measured from the type D Scale-14 (DS14) questionnaire.	baseline
Primary	Cardiovascular events - longitudinal outcome measure.	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.	5-10 years