Myocardial Injury After Elective Coronary Stenting

May 27, 2018 updated by: Haitham Abu Sharar, University Hospital Heidelberg

Identification of Patients at Higher Risk for Myocardial Injury or Type 4a Infarction Following Elective Coronary Artery Stenting

This pilot study aims to identify patients at moderate to high risk for peri-procedural (type 4) myocardial infarction or injury after after undergoing an elective coronary intervention (PCI) as measured by high sensitivity troponin T, who might benefit from more potent antiplatelet therapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

530

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

  • Germany
      • 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

Non-Probability Sample

Study Population

Patients with stable or unknown CAD undergoing elective coronary intervention without receiving additional examination, such as biopsy, Ablation or any other procedure that could lead to myocardial injury resulting in elevation of the cardiac Troponin.

Description

Inclusion Criteria:

  • Stable or unknown coronary artery disease (CAD)
  • Elective coronary intervention
  • Minimum age of 18

Exclusion Criteria:

  • Present acute coronary syndrome (ACS)
  • Age under 18
  • Pregnancy
  • Any additional invasive intervention with potential myocardial injury
  • Non ACS conditions responsible for elevation of cardiac troponin, such as acute pulmonary artery embolism, myocarditis or tachycardia.

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
Patients undergoing elective PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postprocedural myocardial infarction (type 4a) or injury
Time Frame: up to 72 hours after procedure
up to 72 hours after procedure

Collaborators and Investigators

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

Sponsor

University Hospital Heidelberg

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Haitham Abu Sharar, Dr. med., University Hospital Heidelberg
  • Principal Investigator: Evangelos Giannitsis, Prof. Dr., University Hospital 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 (Actual)

April 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 27, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCI MI4a

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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