Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block
Primary Purpose
Acute Coronary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
PCI
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, percutaneous coronary intervention, left bundle branch block
Eligibility 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
Sites / Locations
- Samara Regional Cardiology Dispansery
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
Number of participants survived
Full Information
NCT ID
NCT01494870
First Posted
December 13, 2011
Last Updated
January 7, 2012
Sponsor
Samara Regional Cardiology Dispensary
1. Study Identification
Unique Protocol Identification Number
NCT01494870
Brief Title
Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samara Regional Cardiology Dispensary
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, percutaneous coronary intervention, left bundle branch block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
urgent PCI on admission
Primary Outcome Measure Information:
Title
mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of participants survived
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Duplyakov, MD, PhD
Phone
+79277297273
Email
duplyakov@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Yavelov, MD, PhD
Phone
+79166059047
Email
yavelov@yahoo.com
Facility Information:
Facility Name
Samara Regional Cardiology Dispansery
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Duplyakov, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block
We'll reach out to this number within 24 hrs