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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Samara Regional Cardiology Dispensary.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ass.Prof. Dmitry Duplyakov M.D., Ph.D., Samara Regional Cardiology Dispensary
ClinicalTrials.gov Identifier:
NCT01494870
First received: December 13, 2011
Last updated: January 7, 2012
Last verified: January 2012
  Purpose

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 Intervention
Acute Coronary Syndrome
Procedure: PCI

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

Further study details as provided by Samara Regional Cardiology Dispensary:

Primary Outcome Measures:
  • mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants survived [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PCI
    urgent PCI on admission
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 13, 2011
Last Updated: January 7, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Samara Regional Cardiology Dispensary:
acute coronary syndrome
percutaneous coronary intervention
left bundle branch block

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Bundle-Branch Block
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Heart Block
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on October 19, 2014