Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
1 other identifier
observational
336
1 country
1
Brief Summary
Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2015
CompletedFirst Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedResults Posted
Study results publicly available
January 13, 2023
CompletedJanuary 13, 2023
April 1, 2022
3.7 years
February 6, 2017
June 18, 2021
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myeloperoxidase
Level of serum myeloperoxidase just after sternal closure
Level of serum myeloperoxidase just after sternal closure
Secondary Outcomes (11)
Low Cardiac Output Syndrome
Up to 30 days after surgical procedure
Length of Stay in Intensive Care Unit
During 30 days after procedure or more
Length of Stay in Hospital
During 30 days after procedure or more
Cumulative Dose of Inotrope
Up to 30 days after procedure
Days of Administration of Inotrope
During 30 days after procedure or more
- +6 more secondary outcomes
Other Outcomes (2)
Death
During 30 days after procedure
Stroke
During 30 days after procedure
Study Arms (3)
On-Pump CABG
Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.
Off-Pump CABG
Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.
BH-CABG MSC.
Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation.
Interventions
Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation
Eligibility Criteria
Patients with ischemic heart disease.
You may qualify if:
- ischemic heart disease
You may not qualify if:
- valve disease
- diabetes millitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089, Russia
Biospecimen
Serum from central vein.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Unequal amount of participants in arms (few patients were enrolled in off-pump arm).
Results Point of Contact
- Title
- Nikolay Bunenkov
- Organization
- First State Pavlov Medical University
Study Officials
- STUDY DIRECTOR
Alexander S Nemkov, PhD, MD
PSPbGMU
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 13, 2017
Study Start
September 15, 2015
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
January 13, 2023
Results First Posted
January 13, 2023
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share