NCT01735500

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

November 24, 2012

Last Update Submit

December 6, 2014

Conditions

Coronary Artery Disease

Keywords

Prei-proceduralElevationcardia Troponin Tin stableunknown

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality

    Up to 12 months after procedure

Study Arms (2)

CAG without PCI

CAG with PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \- Stable or unknown CAD

You may not qualify if:

  • \- Acute Coronary Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology - University Hospital of Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Evangelos Giannitsis, Prof. Dr. med.

    Department of Cardiology, University Hospital of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

November 24, 2012

First Posted

November 28, 2012

Study Start

February 1, 2010

Primary Completion

November 1, 2011

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

DE(1)