NCT00761969

Brief Summary

The PID-PAB study aims to test the efficacy of the European Guidelines on Cardiovascular Disease Prevention in patients with peripheral arterial disease. Survival, the rate of major atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and the incidence of revascularization procedures will be compared between a group of patients with stable peripheral arterial disease (PAD) and age- and sex-matched control subjects without PAD. Both groups will be receiving up-to-date medical care according to their cardiovascular risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. Yearly follow-up is planned for 5 years. The PID PAB study aims to test (a) whether stable PAD is still an adverse prognostic indicator in spite of contemporary preventive measures, and (b) to what extent do contemporary preventive measures improve the prognosis of patients with PAD in comparison to historic controls, representing the natural history of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

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

December 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

10 years

First QC Date

September 28, 2008

Results QC Date

September 29, 2015

Last Update Submit

November 12, 2015

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial diseasesecondary preventioncardiovascular /atherothrombotic eventsEuropean guidelinesCardiovascular disease prevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of Major Cardiovascular Events

    Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.

    5 years:

Secondary Outcomes (1)

  • Incidence of Revascularization Procedures

    5 years

Study Arms (2)

PAB

Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.

Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice

Control

Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD

Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice

Interventions

Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical PracticeOTHER

Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice.

ControlPAB

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stable, objectively confirmed PAD, recruited from primary care settings in Slovenia, Europe. Control subjects of comparable age- and sex-distribution, without PAD, recruited from primary care settings in Slovenia, Europe.

You may qualify if:

  • Patients with PAD: ankle-brachial pressure index \<= 0.90
  • Controls: palpable pedal pulses, ankle-brachial pressure index 0.91-1.30

You may not qualify if:

  • Malignancy with a life expectancy \< 5 years
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vascular Diseases, University of Ljubljana Medical Center

Ljubljana, 1000, Slovenia

Location

Related Publications (10)

  • Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6. doi: 10.1056/NEJM199202063260605.

    PMID: 1729621BACKGROUND

  • Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D. Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):538-45. doi: 10.1161/01.atv.19.3.538.

    PMID: 10073955BACKGROUND

  • Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.

    PMID: 11560536BACKGROUND

  • Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

    PMID: 11786451BACKGROUND

  • Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3.

    PMID: 12114036BACKGROUND

  • Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301.

    PMID: 10639539BACKGROUND

  • De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomer K, Perk J, Pyorala K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10. doi: 10.1016/s0195-668x(03)00347-6. No abstract available.

    PMID: 12964575BACKGROUND

  • Giampaoli S, Capewell S, Shelley E, Allender S, Briggs A, Jorgensen T, Labarthe D, Marques-Vidal P, Stegmayr B, Verschuren WM, Zdrojewski T. Foreword. Eur J Cardiovasc Prev Rehabil. 2007 Dec;14 Suppl 3:S1. doi: 10.1097/01.hjr.0000296928.40040.b0. No abstract available.

    PMID: 18091132BACKGROUND

  • Blinc A, Kozak M, Sabovic M, Bozic Mijovski M, Stegnar M, Poredos P, Kravos A, Barbic-Zagar B, Stare J, Pohar Perme M. Survival and event-free survival of patients with peripheral arterial disease undergoing prevention of cardiovascular disease. Int Angiol. 2017 Jun;36(3):216-227. doi: 10.23736/S0392-9590.16.03731-7. Epub 2016 Jun 22.

    PMID: 27332992DERIVED

  • Blinc A, Kozak M, Sabovic M, Bozic M, Stegnar M, Poredos P, Kravos A, Barbic-Zagar B, Pohar Perme M, Stare J; PID-PAB Investigators. Prevention of ischemic events in patients with peripheral arterial disease design, baseline characteristics and 2-year results an observational study. Int Angiol. 2011 Dec;30(6):555-66.

    PMID: 22233617DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood (16 ml) for analysis of inflammatory markers (from serum) and genotyping, to be correlated with clinical outcomes. Anonymity of patients is proveded by coding the samples and the patients clinical records.

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Ales Blinc, MD, DSc
Organization
Department of Vascular Diseases, University of Ljubljana Med Ctr
ales.blinc@kclj.si
+386 1 522 80 32

Study Officials

  • Ales Blinc, MD, DSc

    Dept of Vascular Diseases, University of Ljubljana Med Ctr

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 28, 2008

First Posted

September 30, 2008

Study Start

December 1, 2004

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 17, 2015

Results First Posted

November 17, 2015

Record last verified: 2015-11

Locations

SL(1)