NCT01494870

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

December 13, 2011

Last Update Submit

January 7, 2012

Conditions

Keywords

acute coronary syndromepercutaneous coronary interventionleft bundle branch block

Outcome Measures

Primary Outcomes (1)

  • mortality

    30 days

Secondary Outcomes (1)

  • Number of participants survived

    1 year

Interventions

PCIPROCEDURE

urgent PCI on admission

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • all-comers design

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samara Regional Cardiology Dispansery

Samara, 443070, Russia

Location

MeSH Terms

Conditions

Acute Coronary SyndromeBundle-Branch Block

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dmitry Duplyakov, MD, PhD

CONTACT

Igor Yavelov, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Cardiology Department

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 19, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations