Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01494870
• Other study ID #: SOKKD-01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2011
• Last updated: January 7, 2012
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2012
• Source: Samara Regional Cardiology Dispensary
• Contact: Dmitry Duplyakov, MD, PhD
• Phone: +79277297273
• Email: duplyakov[@]yahoo.com
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to propose new treatment algorithm (strategy) for patients with Acute Coronary Syndrome (ACS) and left bundle-branch block (LBBB).

Description:

Current recommendations on the treatment of acute coronary syndrome (ACS) dictate urgent reperfusion therapy in the case of evolving myocardial infarction with ST-segment elevation (STEMI). Optimal use of PCI (preferably) or thrombolysis in this situation requires a rapid and correct diagnosis.

According to the ESC'2008 and ACC/AHA'2009 focused update guidelines patients admitted to the hospital within 12 hours after the onset of chest pain with new (or presumably new) left bundle-branch block (LBBB) should be treated like patients having STEMI (class I, level A). However, it is well-known that in patients with concomitant LBBB, the ECG manifestations of acute myocardial injury may be masked.

ACS may occur in a patient with "true old" LBBB (when doctor has/has not an ability to compare the new ECG with the previous one) or (presumably) new LBBB.

There is a high risk of non receiving appropriate therapy or of receiving inappropriate therapy (thrombolysis instead of LMWH/UFH/fondaparinux).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 - 75 years

• Ischemic discomfort (ie, ischemic chest pain or equivalent) at rest =20 minutes within previous 24 hours.

• Any (new, presumably new, or old) LBBB on the prehospital (ambulance) or admission ECG.

• Urgent coronary angiography (followed, when indicated, by PCI), ideally within 90 minutes after admission

Exclusion Criteria:

• all-comers design

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Bundle-Branch Block

Intervention

Procedure:
• PCI
urgent PCI on admission

Locations

Country	Name	City	State
Russian Federation	Samara Regional Cardiology Dispansery	Samara

Sponsors (1)

Lead Sponsor	Collaborator
Samara Regional Cardiology Dispensary

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		30 days	Yes
Secondary	Number of participants survived		1 year	Yes