Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block
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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 |
- mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- 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) |
-
Procedure: PCI
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 |
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| Contact: Dmitry Duplyakov, MD, PhD | +79277297273 | duplyakov@yahoo.com |
| Contact: Igor Yavelov, MD, PhD | +79166059047 | yavelov@yahoo.com |
| Russian Federation | |
| Samara Regional Cardiology Dispansery | Not yet recruiting |
| Samara, Russian Federation, 443070 | |
| Principal Investigator: Dmitry Duplyakov, MD, PhD | |
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:
|
Bundle-Branch Block Myocardial Infarction Acute Coronary Syndrome Heart Block Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Myocardial Ischemia Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013