Cardiac CatheterizationNCT00825331
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)
An observational study of Cardiac Catheterization, run by RWTH Aachen University at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Catheterization
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients needing elective cardiac catheterization or PCI or emergency interventions
Who may be able to join
- elective cardiac catheterization or PCI or emergency interventions
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074
About this study
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
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
Read the 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.
- Conditions
- Cardiac Catheterization
- Keywords
- guide wire, cardiac catheterization, ultrasound-guided examination of the access site, graduated scheme, elective and non elective cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of vascular complications by marking of the access site
Measured: 18 months
Secondary outcomes (1)
Improvement of guide wire removal procedure by using the graduated scheme
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Change of location for Investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Stegemann, MD, Principal investigator, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825331
- Sponsor's protocol ID
- Guidewire Management for PTCA
- Status last verified
- Sep 2015
- First submitted
- 19 Jan 2009
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stegemann E, Busch L, Stegemann B, Lauer T, Hoffmann R, Heiss C, Kelm M. Evaluation of a structured training program for arterial femoral sheath removal after percutaneous arterial catheter procedures by assistant personnel. Am J Cardiol. 2015 Apr 1;115(7):879-83. doi: 10.1016/j.amjcard.2015.01.012. Epub 2015 Jan 15.
PubMed 25661570
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00825331
- Acronym / sponsor ID
- Guidewire Management for PTCA
- Conditions
- Cardiac Catheterization
- Keywords
- guide wire, cardiac catheterization, ultrasound-guided examination of the access site, graduated scheme, elective and non elective cardiac catheterization
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change of location for Investigators
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients needing elective cardiac catheterization or PCI or emergency interventions
Key inclusion criteria (1 listed)
- elective cardiac catheterization or PCI or emergency interventions
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decrease of vascular complications by marking of the access site
Time frame: 18 months
1 secondary outcome
Improvement of guide wire removal procedure by using the graduated scheme
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 25661570Stegemann E, Busch L, Stegemann B, Lauer T, Hoffmann R, Heiss C, Kelm M. Evaluation of a structured training program for arterial femoral sheath removal after percutaneous arterial catheter procedures by assistant personnel. Am J Cardiol. 2015 Apr 1;115(7):879-83. doi: 10.1016/j.amjcard.2015.01.012. Epub 2015 Jan 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Stegemann, MD principal investigator
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Catheterization, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of vascular complications by marking of the access site (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.