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

NCT ID: NCT01494870

Last Updated: 2012-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-11-30

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PCI

urgent PCI on admission

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samara Regional Cardiology Dispensary

OTHER

Sponsor Role lead

Responsible Party

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Ass.Prof. Dmitry Duplyakov M.D., Ph.D.

Medical Director, Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samara Regional Cardiology Dispansery

Samara, , Russia

Site Status

Countries

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Russia

Central Contacts

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Dmitry Duplyakov, MD, PhD

Role: CONTACT

+79277297273

Igor Yavelov, MD, PhD

Role: CONTACT

+79166059047

Other Identifiers

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SOKKD-01

Identifier Type: -

Identifier Source: org_study_id

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