Patients With SAT or LT After Stent Implantation (PCI)NCT00652015
Molecular and Cellular Mechanisms of the In-stent-thrombosis
An observational study of Patients With SAT or LT After Stent Implantation (PCI), run by RWTH Aachen University at 1 site in Germany.
Trial summary
In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With SAT or LT After Stent Implantation (PCI)
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to May 2010
- 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 having developed an SAT or LT after stent implantation using PTCA
Who may be able to join
- patients having developed an SAT or LT after stent implantation using PTCA
Who cannot join
- instabel coronary heart diseases,
- systemic autoimmune diseases,
- rheumatic diseases,
- tumors,
- impaired kidney or liver function,
- surgery within the last 3 months,
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular and Cellular Mechanisms of the In-stent-thrombosis. Is it Possible to Predict a In-stent-thrombosis Using Biomarkers?
In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.
Read the detailed description
In this prospective, open, not-randomized, controlled single-center pilot study 80 patients having had an in-stent-thrombosis (40 sub-acute thromboses (SAT), 40 late thromboses (LT)) and a control group of 80 patients having not developed a thrombosis will be compared.
The aim of this study is the establishment of diagnostic markers vor prediction of SAT (detection of CD39- and CD73-activity, respectively)and of LT (EPC-number and function, respectively) correspondingly aiming at the early identification of patients with high risk for developing an in-stent-thrombosis.
- Keywords
- in-stent-thrombosis, CD39, CD73, EPC
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 having developed an in-stent-thrombosis (40 SAT, 40 LT) | |
| 2 | Patients having not developed an in-stent-thrombosis after stent implantation using PTCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively.
Measured: may 08 to may 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Recruitment numbers could not at all been achieved in an acceptable period of time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With SAT or LT After Stent Implantation (PCI)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Investigators
- Burcin Özüyaman, MD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652015
- Sponsor's protocol ID
- EK 039/08
- Status last verified
- Sep 2015
- First submitted
- 31 Mar 2008
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Molecular and Cellular Mechanisms of the In-stent-thrombosis. Is it Possible to Predict a In-stent-thrombosis Using Biomarkers?
- ClinicalTrials.gov ID
- NCT00652015
- Acronym / sponsor ID
- EK 039/08
- Keywords
- in-stent-thrombosis, CD39, CD73, EPC
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment numbers could not at all been achieved in an acceptable period of time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Apr 2008 (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.
In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.
Detailed description
In this prospective, open, not-randomized, controlled single-center pilot study 80 patients having had an in-stent-thrombosis (40 sub-acute thromboses (SAT), 40 late thromboses (LT)) and a control group of 80 patients having not developed a thrombosis will be compared.
The aim of this study is the establishment of diagnostic markers vor prediction of SAT (detection of CD39- and CD73-activity, respectively)and of LT (EPC-number and function, respectively) correspondingly aiming at the early identification of patients with high risk for developing an in-stent-thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients having developed an in-stent-thrombosis (40 SAT, 40 LT) |
| 2 | – | –Patients having not developed an in-stent-thrombosis after stent implantation using PTCA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having developed an SAT or LT after stent implantation using PTCA
Key inclusion criteria (1 listed)
- patients having developed an SAT or LT after stent implantation using PTCA
Key exclusion criteria (7 listed)
- instabel coronary heart diseases,
- systemic autoimmune diseases,
- rheumatic diseases,
- tumors,
- impaired kidney or liver function,
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
The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively.
Time frame: may 08 to may 2010
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.
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.
Burcin Özüyaman, MD principal investigator
RWTH Aachen University
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 Patients With SAT or LT After Stent Implantation (PCI), 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 7 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?
The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively. (time frame: may 08 to may 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.