Myocardial IschemiaNCT03431844
Humanin Isoforms in Cardiac Muscle and Blood Plasma and Major Complications After Cardiac Operation
An observational study of Myocardial Ischemia and Coronary Artery Bypass Surgery, run by University of Tartu at 2 sites in Estonia.
Trial summary
Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation. Hypothesis of the study is that previously described elements are related to each other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Coronary Artery Bypass Surgery
- How many people
- 106 participants
- Where
- 2 sitesEstonia
- Study dates
- 1 Jan 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who have a history of ischemic heart disease and who are going to have an elective on-pump CABG operation.
Who may be able to join
- Age at least 18 years
- Ischemic heart disease in medical history
- Planned on-pump coronary artery bypass graft (CABG) operation
- Signed informed consent by patient
Who cannot join
- Age <18 years
- Planned isolate valve or aortic operation
- Patient is in another study with an intervention
- Absence of signed informed consent
Trial locations and contacts
2 sites in 1 country.
Estonia2 sites
North Estonia Medical Centre
Tallinn, Harju, 13419
Tartu University Hospital
Tartu, Tartu, 51014
About this study
Official title: Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation
Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation.
Hypothesis of the study is that previously described elements are related to each other.
Read the detailed description
Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications).
Specimen collection:
- Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C.
- Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.
- Medical subject headings
- Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
30-day all-cause mortality
Measured: 30 days
Major complications: myocardial infarction.
Diagnosed myocardial infarction.
Measured: 30 days
Major complications: acute kidney injury.
Diagnosed acute kidney failure (KDIGO stage).
Measured: 30 days
Major complications: stroke.
Diagnosed stroke.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital, North Estonia Medical Centre
- Responsible party
- Principal investigator, Henery Kroon, University of Tartu
- Investigators
- Joel Starkopf, MD, PhD, Study director, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431844
- Sponsor's protocol ID
- HN1160
- Status last verified
- Aug 2020
- First submitted
- 18 Jan 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation
- ClinicalTrials.gov ID
- NCT03431844
- Acronym / sponsor ID
- HN1160
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Tartu University Hospital, North Estonia Medical Centre
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation.
Hypothesis of the study is that previously described elements are related to each other.
Detailed description
Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications).
Specimen collection:
- Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C.
- Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who have a history of ischemic heart disease and who are going to have an elective on-pump CABG operation.
Key inclusion criteria (4 listed)
- Age at least 18 years
- Ischemic heart disease in medical history
- Planned on-pump coronary artery bypass graft (CABG) operation
- Signed informed consent by patient
Key exclusion criteria (4 listed)
- Age <18 years
- Planned isolate valve or aortic operation
- Patient is in another study with an intervention
- Absence of signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
30-day all-cause mortality
Major complications: myocardial infarction.
Time frame: 30 days
Diagnosed myocardial infarction.
Major complications: acute kidney injury.
Time frame: 30 days
Diagnosed acute kidney failure (KDIGO stage).
Major complications: stroke.
Time frame: 30 days
Diagnosed stroke.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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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.
Joel Starkopf, MD, PhD study director
Tartu University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia and Coronary Artery Bypass Surgery, run by University of Tartu at 2 sites in Estonia.
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 4 inclusion and 4 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2020.