Acute Myocardial InfarctionVaMISNCT01452178
Vastmanland Myocardial Infarction Study (VaMIS)
An observational study of Acute Myocardial Infarction and Peripheral Artery Disease, run by Uppsala University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Peripheral Artery Disease, Diabetes
- How many people
- 1,008 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2005to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- age less than 18 years
- severly impaired communication capabilities
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Clinical Research, Uppsala University, Västmanland County Hospital
Västerås, SE-72189
About this study
Official title: 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.
Read the 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.
- Keywords
- Cardiovascular diseases, Glucometabolic disorders, Type-D personality
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: basline
Prevalence of type D personality - cross sectional measure.
Type D personality as measured from the type D Scale-14 (DS14) questionnaire.
Measured: baseline
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.
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startNov 2005
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Pär Hedberg, Assoc. Professor, Study chair, Center for Clinical Research, Uppsala University, Västmanland County Hospital, SE-72189 Västerås, SwedenJerzy Leppert, Senior Professor, Principal investigator, Center for Clinical Research, Uppsala University, Västmanland County Hospital, SE-72189 Västerås, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452178
- Sponsor's protocol ID
- VaMIS
- Acronym
- VaMIS
- Status last verified
- May 2023
- First submitted
- 11 Oct 2011
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.2014.08.137. Epub 2014 Aug 28. No abstract available.
PubMed 25223818Conden 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 Sep 22.
PubMed 25243796Selmeryd 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.
PubMed 26374880Conden 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.
PubMed 27128534Hedberg 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.
PubMed 28067203Conden 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):522-533. doi: 10.1177/2047487316687427. Epub 2017 Jan 10.
PubMed 28071958Eriksson 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.2017.05.027. Epub 2017 May 26.
PubMed 28599258Skau 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. Epub 2017 Aug 1.
PubMed 28762762Selmeryd 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: 10.1016/j.jcmg.2017.04.019. Epub 2017 Jul 19.
PubMed 28734926Calais 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.
PubMed 29657058Doerstling 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 2018 May 1.
PubMed 29714603Nilsson 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. eCollection 2018.
PubMed 30533220Nowak 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 events in type 2 diabetes. Diabetologia. 2018 Aug;61(8):1748-1757. doi: 10.1007/s00125-018-4641-z. Epub 2018 May 24.
PubMed 29796748Henriksen 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.
PubMed 29961999Velders 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: 10.1080/03009734.2019.1650141. Epub 2019 Aug 20.
PubMed 31429631
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Peripheral Vascular Disease, Glucometabolic Status, and Type D Personality in Patients With Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT01452178
- Acronym / sponsor ID
- VaMIS / VaMIS
- Keywords
- Cardiovascular diseases, Glucometabolic disorders, Type-D personality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Study start
- Nov 2005
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- age less than 18 years
- severly impaired communication capabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Prevalence of type D personality - cross sectional measure.
Time frame: baseline
Type D personality as measured from the type D Scale-14 (DS14) questionnaire.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Results publication: PubMed 25223818Calais 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.2014.08.137. Epub 2014 Aug 28. No abstract available.
- Results publication: PubMed 25243796Conden 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 Sep 22.
- Results publication: PubMed 26374880Selmeryd 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.
- Results publication: PubMed 27128534Conden 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.
- Results publication: PubMed 28067203Hedberg 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.
- Results publication: PubMed 28071958Conden 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):522-533. doi: 10.1177/2047487316687427. Epub 2017 Jan 10.
- Results publication: PubMed 28599258Eriksson 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.2017.05.027. Epub 2017 May 26.
- Results publication: PubMed 28762762Skau 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. Epub 2017 Aug 1.
- Results publication: PubMed 28734926Selmeryd 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: 10.1016/j.jcmg.2017.04.019. Epub 2017 Jul 19.
- Results publication: PubMed 29657058Calais 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.
- Results publication: PubMed 29714603Doerstling 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 2018 May 1.
- Results publication: PubMed 30533220Nilsson 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. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pär Hedberg, Assoc. Professor study chair
Center for Clinical Research, Uppsala University, Västmanland County Hospital, SE-72189 Västerås, Sweden
Jerzy Leppert, Senior Professor principal investigator
Center for Clinical Research, Uppsala University, Västmanland County Hospital, SE-72189 Västerås, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Peripheral Artery Disease, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452178, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.