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

S

Samara Regional Cardiology Dispensary

Status

Unknown

Conditions

Acute Coronary Syndrome

Treatments

Procedure: PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT01494870
SOKKD-01

Details and patient eligibility

About

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).

Full 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).

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Igor Yavelov, MD, PhD; Dmitry Duplyakov, MD, PhD

Data sourced from clinicaltrials.gov

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