Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00825331
First received: January 19, 2009
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

Periprocedural management of guidewire placement and removal in patients needing cardiac catheterization by use of marking of the access site and removal procedure due to a graduated scheme


Condition
Cardiac Catheterization

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)Using Preprocedural Marking of the Arterial Access Site and a Graduated Scheme for Removal of the Guidewire

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Decrease of vascular complications by marking of the access site [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of guide wire removal procedure by using the graduated scheme [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients for elective catheterization without special risks
2
patients for elective catheterization with special risks
3
patients for PCI without GP IIb/IIIa
4
Patients for PCI with GPIIb/IIIa and emergencies

Detailed Description:

Before elective cardiac catheterization, patients undergo an ultrasound-guided marking of the bifurcation of the common femoral artery in order to access the vascular complication rate compared tho those of non-marked patients.

Concerning the removal of the guided wire, patients will be treated due to a graduated scheme taking care of different risk levels. This procedure should improve clinical routine, but the efficacy and safety have to be assessed. Depending on the risk level, the guide wire will be removed either by an ambulance officer or emergency medical technician, assistant personal of the cardiac catheterization operating room or by a physician specialist in intensive care. Both methods should lead to quality assurance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients needing elective cardiac catheterization or PCI or emergency interventions

Criteria

Inclusion Criteria:

  • elective cardiac catheterization or PCI or emergency interventions

Exclusion Criteria:

-

  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: NCT00825331

Contacts
Contact: Emilia Stegemann, MD 0049-241 ext 8080092 EStegemann@ukaachen.de

Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine Recruiting
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Emilia Stegemann, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00825331     History of Changes
Other Study ID Numbers: Guidewire Management for PTCA
Study First Received: January 19, 2009
Last Updated: May 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
guide wire
cardiac catheterization
ultrasound-guided examination of the access site
graduated scheme
elective and non elective cardiac catheterization

ClinicalTrials.gov processed this record on July 22, 2014