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

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

      • Heidelberg, Germany, 69120
        • Department of Cardiology - University Hospital of Heidelberg

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
CAG without PCI
CAG with PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular mortality
Time Frame: Up to 12 months after procedure
Up to 12 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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