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Myocardial Injury After Elective Coronary Stenting

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ClinicalTrials.gov Identifier: NCT01986621
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Haitham Abu Sharar, University Hospital Heidelberg

Brief Summary:
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.

Condition or disease
Coronary Artery Disease

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Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Patients at Higher Risk for Myocardial Injury or Type 4a Infarction Following Elective Coronary Artery Stenting
Actual Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Group/Cohort
Patients undergoing elective PCI



Primary Outcome Measures :
  1. Postprocedural myocardial infarction (type 4a) or injury [ Time Frame: up to 72 hours after procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986621


Locations
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Germany
Department of Cardiology - University Hospital of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
AstraZeneca
Investigators
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Principal Investigator: Haitham Abu Sharar, Dr. med. University Hospital Heidelberg
Principal Investigator: Evangelos Giannitsis, Prof. Dr. University Hospital Heidelberg
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Responsible Party: Haitham Abu Sharar, Physician, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01986621    
Other Study ID Numbers: PCI MI4a
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Keywords provided by Haitham Abu Sharar, University Hospital Heidelberg:
Percutaneous Coronary Intervention
Cardiac troponin
Antiplatelet therapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases