NCT01452178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

5.5 years

First QC Date

October 11, 2011

Last Update Submit

May 10, 2023

Conditions

Acute Myocardial InfarctionPeripheral Artery DiseaseDiabetes

Keywords

Cardiovascular diseasesGlucometabolic disordersType-D personality

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Prevalence of type D personality - cross sectional measure.

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

    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.

    5-10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • age less than 18 years
  • severly impaired communication capabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Research, Uppsala University, Västmanland County Hospital

Västerås, SE-72189, Sweden

Location

Related Publications (18)

  • 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.

    PMID: 25223818RESULT

  • 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 Sep 22.

    PMID: 25243796RESULT

  • 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.

    PMID: 26374880RESULT

  • 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.

    PMID: 27128534RESULT

  • 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.

    PMID: 28067203RESULT

  • 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):522-533. doi: 10.1177/2047487316687427. Epub 2017 Jan 10.

    PMID: 28071958RESULT

  • 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.2017.05.027. Epub 2017 May 26.

    PMID: 28599258RESULT

  • 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. Epub 2017 Aug 1.

    PMID: 28762762RESULT

  • 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: 10.1016/j.jcmg.2017.04.019. Epub 2017 Jul 19.

    PMID: 28734926RESULT

  • 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.

    PMID: 29657058RESULT

  • 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 2018 May 1.

    PMID: 29714603RESULT

  • 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. eCollection 2018.

    PMID: 30533220RESULT

  • 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 events in type 2 diabetes. Diabetologia. 2018 Aug;61(8):1748-1757. doi: 10.1007/s00125-018-4641-z. Epub 2018 May 24.

    PMID: 29796748RESULT

  • 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.

    PMID: 29961999RESULT

  • 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: 10.1080/03009734.2019.1650141. Epub 2019 Aug 20.

    PMID: 31429631RESULT

  • 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/s12905-019-0851-x.

    PMID: 31842885RESULT

  • 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 EMWJ, van Veldhuisen DJ, Wang Y, Kupper N. Type D Personality as a Risk Factor for Adverse Outcome in Patients With Cardiovascular Disease: An Individual Patient-Data Meta-analysis. Psychosom Med. 2023 Feb-Mar 01;85(2):188-202. doi: 10.1097/PSY.0000000000001164. Epub 2023 Jan 9.

    PMID: 36640440RESULT

  • 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 area. BMJ Open. 2022 Jul 27;12(7):e057562. doi: 10.1136/bmjopen-2021-057562.

    PMID: 35896296RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum.

MeSH Terms

Conditions

Peripheral Arterial DiseaseDiabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPeripheral Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pär Hedberg, Assoc. Professor

    Center for Clinical Research, Uppsala University, Västmanland County Hospital, SE-72189 Västerås, Sweden

    STUDY CHAIR

  • Jerzy Leppert, Senior Professor

    Center for Clinical Research, Uppsala University, Västmanland County Hospital, SE-72189 Västerås, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 14, 2011

Study Start

November 1, 2005

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

SE(1)