Myocardial Injury After Elective Coronary Stenting

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986621
• Other study ID #: PCI MI4a
• Status: Completed
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: May 2018
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Department of Cardiology - University Hospital of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprocedural myocardial infarction (type 4a) or injury		up to 72 hours after procedure