Microparticles and the Risk of Re-stenosis Following Balloon Angioplasty in Patients With Peripheral Arterial Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital Inselspital, Berne.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Bern
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01422343
First received: March 28, 2011
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

Although microparticles have been well-documented as mediators of inflammation and coagulation in various cardio-vascular disease events, it is currently not known how Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences microparticle numbers, phenotype and distribution pre- and post interventionally and how they are related to or affect the incidence of early re-stenosis - or if indeed they may be used to predict patients at risk of early re-stenosis.


Condition Intervention
Peripheral Vascular Diseases
Procedure: percutaneous transluminal angioplasty femoro-popliteal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Microparticles With Risk of Early Re-stenosis After Percutaneous Transluminal Angioplasty in Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Number of participants with early re-stenosis post-angioplasty [ Time Frame: 6 month post-angioplasty ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of and changes in circulating cell-derived microparticles, measured by flow cytometric analysis of peripheral blood samples, and correlation with early re-stenosis post-PTA [ Time Frame: 6 months post-angioplasty ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: percutaneous transluminal angioplasty femoro-popliteal
percutaneous transluminal angioplasty femoro-popliteal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients (male and female) with peripheral arterial disease presenting at the angiology clinic, Bern University Hospital

Criteria

Inclusion Criteria:

  • male or female
  • 60-85 years
  • femoro-popliteal stenosis
  • TASC B or C category
  • HBA1c <9%, if diabetic
  • creatinine <130µg/ml
  • blood pressure <160/95mmHg
  • thrombocyte aggregation inhibitors or coumarine derivatives

Exclusion Criteria

  • <60 or >85 years
  • stenosis not in femoro-popliteal axis
  • TASC A or D category
  • HBA1c >9%, if diabetic
  • creatinine >130µg/ml
  • blood pressure >160/95mmHg
  • major trauma
  • malignancy
  • anti-phospholipid syndrome
  • relevant hepatic disease
  • major operation within 1 month of enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422343

Locations
Switzerland
University Clinic und Policlinic for Angiology, Bern University Hospital
Bern, Switzerland, 3010
Institute of Pathology, University of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Principal Investigator: Iris Baumgartner, DMD Bern University Hospital
  More Information

Publications:
Responsible Party: Prof. Iris Baumgartner, Bern University Hospital
ClinicalTrials.gov Identifier: NCT01422343     History of Changes
Other Study ID Numbers: 068/09
Study First Received: March 28, 2011
Last Updated: August 22, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
peripheral arterial disease
cell-derived microparticles
immunity, innate
blood coagulation

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 28, 2014