Myocardial Injury After Elective Coronary Stenting | NCT01986621

Studies
Myocardial Injury After Elective Coronary Stenting

NCT01986621

Sponsor

University Hospital Heidelberg

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

530Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Mar 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Nov 15, 2013

First Posted Date

Nov 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2018

Last Update Posted Date

May 30, 2018Actual

Name	Class
AstraZeneca	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

530Actual

Label	Type	Description	Intervention Names
Patients undergoing elective PCI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haitham Abu Sharar, Dr. med.	University Hospital Heidelberg	Principal Investigator
Evangelos Giannitsis, Prof. Dr.	University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology - University Hospital of Heidelberg		Heidelberg		69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided