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hsTnT After Elective Coronary Angiography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haitham Abu Sharar, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01735500
First received: November 24, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rise of hscTnT After Elective Coronary Angiography Without Coronary Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: Up to 12 months after procedure ] [ Designated as safety issue: No ]

Enrollment: 545
Study Start Date: February 2010
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
CAG without PCI
CAG with PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

- Stable or unknown CAD

Exclusion Criteria:

- Acute Coronary Syndrome

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735500

Locations
Germany
Department of Cardiology - University Hospital of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Evangelos Giannitsis, Prof. Dr. med. Department of Cardiology, University Hospital of Heidelberg
  More Information

No publications provided

Responsible Party: Haitham Abu Sharar, Physician, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01735500     History of Changes
Other Study ID Numbers: hsTnT Elective CAG
Study First Received: November 24, 2012
Last Updated: November 27, 2012
Health Authority: Germany: University Hospital Heidelberg

Keywords provided by University Hospital Heidelberg:
Prei-procedural
Elevation
cardia Troponin T
in stable
unknown

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013