Finding LCX AMI With Posterior ECG LeadS
FLAWLESs
Clinical Impact of Pre-hospital Posterior ECG Leads Implementation for Identifying Occlusion of Left Circumflex Coronary Artery in ST Segment Elevation Myocardial Infarction
1 other identifier
observational
1,200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 28, 2019
March 1, 2019
2.6 years
May 26, 2016
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with LCX occlusion as culprit artery in the intervention group compared to the control group
Day one - culprit lesion treated with primary PCI
Secondary Outcomes (1)
Proportion of patients in the intervention group with STEMI involving LCX artery, non-diagnostic standard 12-lead ECG and ST segment elevation >0,5 mm in ≥2 leads in posterior ECG leads (V7-V9).
Day one - culprit lesion treated with primary PCI
Study Arms (2)
Control
Intervention
Interventions
Conventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome.
Recording posterior ECG leads (V7, V8 and V9) in addition to standard 12-lead ECG for identifying STEMI involving left cirumflex coronary artery.
Eligibility Criteria
The intervention group will contain STEMI patients referred directly from the pre-hospital setting to PCI-center for primary PCI during study periode. In these patients, both standard 12-lead ECG and ECG with V7-V9 leads will be recorded and tele-transmitted to the PCI-center.
You may qualify if:
- 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.
You may not qualify if:
- STEMI patients treated with primary PCI and no ECG with V7-V9 leads.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Nykøbing Falster County Hospitalcollaborator
- Region Sjællandcollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jens Kastrup, MD,Professor
Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 2, 2016
Study Start
February 1, 2017
Primary Completion
August 31, 2019
Study Completion
December 1, 2019
Last Updated
March 28, 2019
Record last verified: 2019-03