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

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ClinicalTrials.gov Identifier: NCT01494870
Recruitment Status : Unknown
Verified January 2012 by Ass.Prof. Dmitry Duplyakov M.D., Ph.D., Samara Regional Cardiology Dispensary.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2011
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ass.Prof. Dmitry Duplyakov M.D., Ph.D., Samara Regional Cardiology Dispensary

Brief 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).

Condition or disease Intervention/treatment
Acute Coronary Syndrome Procedure: PCI

Detailed 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: PCI
    urgent PCI on admission


Primary Outcome Measures :
  1. mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Number of participants survived [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494870


Contacts
Contact: Dmitry Duplyakov, MD, PhD +79277297273 duplyakov@yahoo.com
Contact: Igor Yavelov, MD, PhD +79166059047 yavelov@yahoo.com

Locations
Russian Federation
Samara Regional Cardiology Dispansery Not yet recruiting
Samara, Russian Federation, 443070
Principal Investigator: Dmitry Duplyakov, MD, PhD         
Sponsors and Collaborators
Samara Regional Cardiology Dispensary

Responsible Party: Ass.Prof. Dmitry Duplyakov M.D., Ph.D., Medical Director, Cardiology Department, Samara Regional Cardiology Dispensary
ClinicalTrials.gov Identifier: NCT01494870     History of Changes
Other Study ID Numbers: SOKKD-01
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012

Keywords provided by Ass.Prof. Dmitry Duplyakov M.D., Ph.D., Samara Regional Cardiology Dispensary:
acute coronary syndrome
percutaneous coronary intervention
left bundle branch block

Additional relevant MeSH terms:
Acute Coronary Syndrome
Bundle-Branch Block
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Block
Arrhythmias, Cardiac
Pathologic Processes