Finding LCX AMI With Posterior ECG LeadS

NCT ID: NCT02788799

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-12-31

Brief Summary

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Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the criterion usually used in practice to identify patients with acute coronary artery occlusion and is essential for the direct and acute referral of patients for primary PCI. However, ECG does not always reflect changes in the posterior wall of the heart, often equivalent to the left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of LCX as culprit artery in STEMI populations. There is a general concern that some patients with genuine acute occlusion of LCX may present without ST segment elevation and be denied reperfusion therapy, resulting in larger infarction and worse outcome.

The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the clinical impact of this implementation: In comparison to a control cohort of STEMI patients diagnosed with a pre-hospital standard 12-lead ECG prior study start, the investigators hypothesize that introducing V7-V9 leads as a clinical routine in the pre-hospital setting will identify patients with STEMI involving LCX and with a non-diagnostic standard 12-lead ECG.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Control

Standard 12-Lead ECG

Intervention Type OTHER

Conventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome.

Intervention

Standard 12-Lead ECG

Intervention Type OTHER

Conventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome.

Posterior ECG Leads

Intervention Type OTHER

Recording posterior ECG leads (V7, V8 and V9) in addition to standard 12-lead ECG for identifying STEMI involving left cirumflex coronary artery.

Interventions

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Standard 12-Lead ECG

Conventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome.

Intervention Type OTHER

Posterior ECG Leads

Recording posterior ECG leads (V7, V8 and V9) in addition to standard 12-lead ECG for identifying STEMI involving left cirumflex coronary artery.

Intervention Type OTHER

Other Intervention Names

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Posterior Leads (V7, V8 and V9)

Eligibility Criteria

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Inclusion Criteria

* All STEMI patients referred directly from the pre-hospital setting, treated with primary PCI and with available standard 12-lead ECG and ECG with V7-V9 leads.

Exclusion Criteria

* STEMI patients treated with primary PCI and no ECG with V7-V9 leads.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nykøbing Falster County Hospital

OTHER

Sponsor Role collaborator

Region Sjælland

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Yama Fakhri

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Kastrup, MD,Professor

Role: STUDY_CHAIR

Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Yama Fakhri, MD

Role: CONTACT

+4535451196

Jens Kastrup, MD, Professor

Role: CONTACT

+4535452819

Facility Contacts

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Yama Fakhri, MD

Role: primary

Other Identifiers

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FLAWLESS-16-YF

Identifier Type: -

Identifier Source: org_study_id

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