TIII Over TI in Subjects With Myocardial Infarction (T-infarction)

February 16, 2017 updated by: Dr. Fikret Er, University of Cologne

Assessment of T Wave Changes of Patients With Acute Non-ST-elevation Myocardial Infarction

Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII>TI).

Study Type

Observational

Enrollment (Actual)

903

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with acute myocardial infarction without ST segment elevation

Description

Inclusion Criteria:

  • NSTEMI and PCI

Exclusion Criteria:

  • NSTEMI without percutaneous intervention

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TIII>TI
Subjects with TIII>TI in initial ECG
Other: Non interventional study
retrospective noninterventional study
Non TIII>TI
Subjects without TIII>TI in initial ECG
Other: Non interventional study
retrospective noninterventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction size
Time Frame: 5 Days
Assessment of myocardial damage using biomarkers
5 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with coronary artery
Time Frame: 1 day
Assessment of association of infarct related artery and ECG changes
1 day

Collaborators and Investigators

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

Sponsor

University of Cologne

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 (Actual)

January 1, 2011

Primary Completion (Actual)

September 30, 2013

Study Completion (Actual)

January 15, 2017

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Twave1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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