Finding LCX AMI With Posterior ECG LeadS

Myocardial Infarction Clinical Trial

— FLAWLESs  

Official title:

Clinical Impact of Pre-hospital Posterior ECG Leads Implementation for Identifying Occlusion of Left Circumflex Coronary Artery in ST Segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02788799
• Other study ID #: FLAWLESS-16-YF
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Rigshospitalet, Denmark
• Contact: Yama Fakhri, MD
• Phone: +4535451196
• Email: yama.said.fakhri[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: Intervention group:

• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Nykøbing Falster County Hospital, Region Sjælland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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