Peripheral Artery Disease in Vastmanland (PADVa)
This study has been completed.
Sponsor:
Uppsala University
Collaborator:
Västmanland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01452165
First received: October 11, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
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Purpose
The main purposes of this study are:
- to describe the prevalence and degree of reduced left ventricular function and hypertrophy in patients with peripheral arterial disease in comparison to controls from the general population,
- to evaluate factors of importance to left ventricular dysfunction and hypertrophy in patients with peripheral arterial disease, and
- to assess the impact of cardiac function and left ventricular hypertrophy on long-term prognosis in patients with peripheral artery disease.
| Condition |
|---|
|
Peripheral Vascular Diseases Heart Failure Ventricular Dysfunction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa). |
Resource links provided by NLM:
Further study details as provided by Uppsala University:
Primary Outcome Measures:
- Left ventricular ejection fraction (cross-sectional outcome measure) [ Time Frame: baseline ] [ Designated as safety issue: No ]LVEF obtained by echocardiographic biplane disk summation method. In the cross-sectional study, the mean value of LVEF and the prevalence of reduced LVEF (LVEF < 50%) in the patient group will be compared to the control group.
- 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.
- Left ventricular mass (cross-sectional outcome measure) [ Time Frame: baseline ] [ Designated as safety issue: No ]Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.
Secondary Outcome Measures:
- Wall motion score index (WMSI) [ Time Frame: baseline ] [ Designated as safety issue: No ]Left ventricular wall motion score according to the American Society of Echocardiopgraphy.
- Echocardiographic left ventricular filling variables [ Time Frame: baseline ] [ Designated as safety issue: No ]Echocardiographic variables for evaluation of left ventricular diastolic function (e.g. E/A- and E/e'-ratios).
Biospecimen Retention: Samples With DNA
Whole blood and serum.
| Enrollment: | 457 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Left ventricular dysfunction is often a consequence of coronary heart disease (CHD). CHD is prevalent among patients with peripheral artery disease. However, there is limited data regarding left ventricular morphology and function in those patients. In the cross-sectional part of this study we will describe the prevalence of reduced cardiac function and left ventricular hypertrophy in a cohort of patients with peripheral artery disease. The patient outcomes will be compared to control subjects randomly selected from the general population in a case-control design. Further, clinical and genetic determinants of cardiac dysfunction in the patient cohort will be identified. In the longitudinal part of the study, the impact of cardiac function and morphology on cardiovascular mortality and morbidity will be evaluated in the cohort.
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 referred to the Ultrasound laboratory of the Vascular Surgery Department for evaluation of known or suspected vascular disease.
Criteria
Inclusion Criteria:
Fulfillment of at least one of the following criteria:
- ankle-brachial-index (ABI) <= 0.9, or
- stenosis of > 30% of the internal carotid artery, or
- symptoms typical for claudication and corresponding stenotic findings on the ultrasound examination.
Exclusion Criteria:
- age less than 18 years
- severly impaired communication capabilities
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452165
Locations
| Sweden | |
| Center of Clinical Research, Uppsala university, Central Hospital | |
| Västerås, Sweden, SE-72189 | |
Sponsors and Collaborators
Uppsala University
Västmanland County Council, Sweden
Investigators
| Principal Investigator: | Pär Hedberg, MD, PhD | Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden |
| Study Chair: | Jerzy Leppert, MD, PhD | Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden |
More Information
No publications provided
| Responsible Party: | Uppsala University |
| ClinicalTrials.gov Identifier: | NCT01452165 History of Changes |
| Other Study ID Numbers: | PADVa |
| 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 Hypertrophy, Left ventricle Echocardiography Prognosis |
Additional relevant MeSH terms:
|
Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Ventricular Dysfunction |
Heart Diseases Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on June 13, 2013