FLAWLESs
Clinical Impact of Pre-hospital Posterior ECG Leads Implementation for Identifying Occlusion of Left Circumflex Coronary Artery in ST Segment Elevation Myocardial Infarction
Sponsor study identifier
observational
1,200
1 country
1
Study Start
February 1, 2017
Actual (reported)Primary Completion
August 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 26, 2016
Actual (reported)June 2, 2016
Actual (reported)February 1, 2017
Actual (reported)August 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
Rigshospitalet
Copenhagen, Denmark
Jens Kastrup, MD,Professor
Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark
First Submitted
May 26, 2016
First Posted
June 2, 2016
Study Start
February 1, 2017
Actual (reported)Primary Completion
August 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
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Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 28, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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