Ischemic Heart DiseaseNCT03050489

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Ischemic Heart Disease, Coronary Artery Disease, Ischemic Reperfusion Injury
What is being tested?: On-Pump CABG., Off-Pump CABG. and BH-CABG MSC.
Type of treatment: Surgery or procedure
How many people: 336 participants
Where: 1 siteRussia
Study dates: 15 Sep 2015to 31 May 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
Adult, Older adult

Study population: Patients with ischemic heart disease.

Who may be able to join

ischemic heart disease

Who cannot join

valve disease
diabetes millitus

Trial locations and contacts

1 site in 1 country.

Russia1 site

First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089

Other trials in Russia

About this study

Official title: AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

Read the detailed description

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.

Conditions: Ischemic Heart Disease, Coronary Artery Disease, Ischemic Reperfusion Injury, CABG
Being tested: On-Pump CABG., Off-Pump CABG., BH-CABG MSC.
Keywords: CABG, Off-Pump CABG, On-Pump CABG, ischemic-reperfusion injury during CABG, comparison of On- and Off- Pump CABG, Ischemic Heart Disease, Myocardial ischemia-reperfusion and myeloperoxidase, Myocardial ischemia-reperfusion biomarkers
Medical subject headings: Myocardial Ischemia, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

On-Pump CABG.Procedure or surgery
Standard On-Pump CABG.
Off-Pump CABG.Procedure or surgery
Standard Off-Pump CABG.
BH-CABG MSC.Procedure or surgery
Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation

Study groups in NCT03050489
Study group	Role	What they receive
On-Pump CABG		Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass. Receives: Procedure: On-Pump CABG.
Off-Pump CABG		Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass. Receives: Procedure: Off-Pump CABG.
BH-CABG MSC.		Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation. Receives: Procedure: BH-CABG MSC.

What is being measured

The primary outcome is the main question the study is designed to answer.

Myeloperoxidase
Level of serum myeloperoxidase just after sternal closure
Measured: Level of serum myeloperoxidase just after sternal closure

Secondary outcomes (11)

Low Cardiac Output Syndrome
Low cardiac output syndrome up to 30 days after procedure. Cardiac index (CI) was measured by invasive methods. Low cardiac output syndrome was registered when CI <2.2.
Measured: Up to 30 days after surgical procedure
Length of Stay in Intensive Care Unit
Length of stay in intensive care unit after operation.
Measured: During 30 days after procedure or more
Length of Stay in Hospital
Length of stay in hospital
Measured: During 30 days after procedure or more
Cumulative Dose of Inotrope
Calculated according: Cumulative dose of inotrope = Days dose of inotrope * days of administration of inotrope
Measured: Up to 30 days after procedure
Days of Administration of Inotrope
Period of inotrope administration
Measured: During 30 days after procedure or more
Pulmonary Ventilation
Length of pulmonary ventilation
Measured: During 30 days after procedure or more
Systolic Function
Measured with echocardiography (Ejection Fraction)
Measured: Up to 14 days after surgical procedure
Diastolic Function
Measured with echocardiography (End-Diastolic Volume)
Measured: Up to 14 days after surgical procedure
Number of Participants With Reoperation
Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index<2.2.
Measured: Up to 30 days after procedure
Renal Dysfunction
Serum creatinine level after surgical operation larger than 25% level before operation
Measured: Perioperative (before sternotomy and after sternal closure)
Atrial Fibrillation.
New onset atrial fibrillation after operation.
Measured: Up to 30 days after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201531 May 2019

First posted13 Feb 2017
Study start15 Sep 2015
Primary completion31 May 2019
Study completion31 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 336 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03050489
Sponsor's protocol ID: AMIRI-CABG 03/17-11
Status last verified: Apr 2022
First submitted: 6 Feb 2017
Last updated: 13 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
ClinicalTrials.gov ID: NCT03050489
Acronym / sponsor ID: AMIRI-CABG 03/17-11
Conditions: Ischemic Heart Disease, Coronary Artery Disease, Ischemic Reperfusion Injury, CABG
Keywords: CABG, Off-Pump CABG, On-Pump CABG, ischemic-reperfusion injury during CABG, comparison of On- and Off- Pump CABG, Ischemic Heart Disease, Myocardial ischemia-reperfusion and myeloperoxidase, Myocardial ischemia-reperfusion biomarkers
Study type: Observational
Recruitment status: Completed
Enrolment: 336 participants (actual)
Lead sponsor: St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
Study start: 15 Sep 2015 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 13 Feb 2017 (actual)
Results: Posted 13 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
On-Pump CABG	–	Procedure: On-Pump CABG.Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.
Off-Pump CABG	–	Procedure: Off-Pump CABG.Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.
BH-CABG MSC.	–	Procedure: BH-CABG MSC.Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation.

Who may qualify

Ages: 30 to 80 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients with ischemic heart disease.

Key inclusion criteria (1 listed)

ischemic heart disease

Key exclusion criteria (2 listed)

valve disease
diabetes millitus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
On-Pump CABG.Standard On-Pump CABG.	Procedure or surgery	On-Pump CABG
Off-Pump CABG.Standard Off-Pump CABG.	Procedure or surgery	Off-Pump CABG
BH-CABG MSC.Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation	Procedure or surgery	BH-CABG MSC.

Primary outcome

Myeloperoxidase
Time frame: Level of serum myeloperoxidase just after sternal closure
Level of serum myeloperoxidase just after sternal closure

11 secondary outcomes

Low Cardiac Output Syndrome
Time frame: Up to 30 days after surgical procedure
Length of Stay in Intensive Care Unit
Time frame: During 30 days after procedure or more
Length of Stay in Hospital
Time frame: During 30 days after procedure or more
Cumulative Dose of Inotrope
Time frame: Up to 30 days after procedure
Days of Administration of Inotrope
Time frame: During 30 days after procedure or more
Pulmonary Ventilation
Time frame: During 30 days after procedure or more
Systolic Function
Time frame: Up to 14 days after surgical procedure
Diastolic Function
Time frame: Up to 14 days after surgical procedure
Number of Participants With Reoperation
Time frame: Up to 30 days after procedure
Renal Dysfunction
Time frame: Perioperative (before sternotomy and after sternal closure)
Atrial Fibrillation.
Time frame: Up to 30 days after procedure

Results and safety

Results posted to the registry on 13 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
On-Pump CABG	128	128
Off-Pump CABG	181	175
BH-CABG MSC.	27	27

Primary outcome: Myeloperoxidase

Time frame: Level of serum myeloperoxidase just after sternal closure. Median (Inter-Quartile Range). Unit: g/L

Measure	On-Pump CABG n = 128	Off-Pump CABG n = 175	BH-CABG MSC. n = 27
Value	184.3 (135.01 to 250.0)	66.5 (41.33 to 135.82)	144.71 (95.04 to 284.92)

Population analysed: Patients after coronary artery bypass grafting

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days follow up. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
On-pump CABG	15 of 128 (11.7%)	1 of 128 (0.8%)	15 of 128
Off-pump CABG	15 of 175 (8.6%)	0 of 175 (0%)	15 of 175
Pump-assisted CABG	1 of 27 (3.7%)	1 of 27 (3.7%)	0 of 27

Limitations and caveats (from the sponsor): Unequal amount of participants in arms (few patients were enrolled in off-pump arm).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ischemic Heart Disease

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander S Nemkov, PhD, MD study director

PSPbGMU

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myeloperoxidase (time frame: Level of serum myeloperoxidase just after sternal closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.