- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735500
hsTnT After Elective Coronary Angiography
December 6, 2014 updated by: Haitham Abu Sharar, University Hospital Heidelberg
Rise of hscTnT After Elective Coronary Angiography Without Coronary Intervention
A prospective Study, aiming to understand and analyse the key role of the novel High Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated coronary angiography without receiving any additional intervention.
The peri-procedural elevation of the hsTnT indicates some other factors being responsible for the elevation of the hsTnT in absence of an acute coronary syndrome, such as physiological components or micro-injuries.
A one year follow-up has been collected.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
545
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Heidelberg, Germany, 69120
- Department of Cardiology - University Hospital of Heidelberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Consecutive patients with stable or unknown CAD undergoing CAG with/or without PCI.
Patients receiving additional examination, such as biopsy, Ablation or any other procedure that could lead to myocardial injury resulting in elevation of the cardiac Troponin are being excluded, as well as Patients with acute coronary syndrome.
Description
Inclusion Criteria:
- Stable or unknown CAD
Exclusion Criteria:
- Acute Coronary Syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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CAG without PCI
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CAG with PCI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular mortality
Time Frame: Up to 12 months after procedure
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Up to 12 months after procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evangelos Giannitsis, Prof. Dr. med., Department of Cardiology, University Hospital of Heidelberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 24, 2012
First Submitted That Met QC Criteria
November 27, 2012
First Posted (Estimate)
November 28, 2012
Study Record Updates
Last Update Posted (Estimate)
December 9, 2014
Last Update Submitted That Met QC Criteria
December 6, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hsTnT Elective CAG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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