Coronary Artery DiseaseNCT03179137
Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium
An observational study of Coronary Artery Disease and Diabetes Mellitus, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
Cardiac ischemia is a common pathological condition, known to elicit multiple pathological processes at the cellular level. One of the most affected is thought to be cellular metabolism, key for the adequate cardiac function. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Mitochondrial Metabolism Disorders
- What is being tested?
- Standard therapy
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2016to 1 Oct 2021
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodynamically stable patients with coronary artery disease diagnosed with angiography with indication for coronary artery bypass grafting surgery
Who may be able to join
- Coronary artery disease
- Indication for coronary artery bypass grafting surgery
Who cannot join
- Emergency patients
- Patients with LV ejection fraction (LVEF) below 30%
- Patients with severe renal, hepatic or pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathophysiological Mechanisms Elicited by Ischemia and Metabolic Co-morbidities in Myocardium of Patients With Coronary Artery Disease
Cardiac ischemia is a common pathological condition, known to elicit multiple pathological processes at the cellular level. One of the most affected is thought to be cellular metabolism, key for the adequate cardiac function. The aim is to study mitochondrial bioenergetic function, interaction with other cellular systems and influence of several co-morbidities in myocardium of the affected patients.
Read the detailed description
Coronary artery disease, one of the most common pathologies in the developed world, causes hypoperfusion of myocardial tissue, usually evident by the presence of anginal pain. This myocardial ischemia elicits alterations in normal cardiomyocyte physiology, which gradually deteriorate cellular function, affecting the performance of the entire organ. The condition is frequently further complicated (and aggravated) by the presence of various co-morbidities, such as diabetes mellitus. The primary aim of this study is to investigate the cardiomyocyte bioenergetics and the consequences of potentially reduced mitochondrial metabolic function in ischemic heart, and evaluate the potential contribution of other conditions, primarily ones affecting metabolic homeostasis.
- Being tested
- Standard therapy
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard therapyOther
Patients with therapy prescribed independent of the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial oxygen consumption (rate of oxygen consumption per milligram of left ventricular tissue)
Mitochondrial respiration in nmol O2/minute/mg of tissue weight will be measured as an indicator of mitochondrial ATP production capacity, using different metabolic substrates
Measured: 2016-2020
Myocardial production of reactive oxygen species
Myocardial production of reactive oxygen species will be measured using electron paramagnetic resonance and fluorometry
Measured: 2016-2020
Secondary outcomes (1)
Anti-cardiolipin antibodies in the blood of patients with symptoms of cardiac ischemia
Anticardiolipin antibodies assessed in venous blood of patients with angina pectoris undergoing coronary angiography
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Oct 2016
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179137
- Sponsor's protocol ID
- 2181-198-03
- Status last verified
- Jun 2020
- First submitted
- 30 May 2017
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Mechanisms Elicited by Ischemia and Metabolic Co-morbidities in Myocardium of Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03179137
- Acronym / sponsor ID
- 2181-198-03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 7 Jun 2017 (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.
Cardiac ischemia is a common pathological condition, known to elicit multiple pathological processes at the cellular level. One of the most affected is thought to be cellular metabolism, key for the adequate cardiac function. The aim is to study mitochondrial bioenergetic function, interaction with other cellular systems and influence of several co-morbidities in myocardium of the affected patients.
Detailed description
Coronary artery disease, one of the most common pathologies in the developed world, causes hypoperfusion of myocardial tissue, usually evident by the presence of anginal pain. This myocardial ischemia elicits alterations in normal cardiomyocyte physiology, which gradually deteriorate cellular function, affecting the performance of the entire organ. The condition is frequently further complicated (and aggravated) by the presence of various co-morbidities, such as diabetes mellitus. The primary aim of this study is to investigate the cardiomyocyte bioenergetics and the consequences of potentially reduced mitochondrial metabolic function in ischemic heart, and evaluate the potential contribution of other conditions, primarily ones affecting metabolic homeostasis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodynamically stable patients with coronary artery disease diagnosed with angiography with indication for coronary artery bypass grafting surgery
Key inclusion criteria (2 listed)
- Coronary artery disease
- Indication for coronary artery bypass grafting surgery
Key exclusion criteria (3 listed)
- Emergency patients
- Patients with LV ejection fraction (LVEF) below 30%
- Patients with severe renal, hepatic or pulmonary disease
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 |
|---|---|---|
| Standard therapyPatients with therapy prescribed independent of the study | Other | – |
Primary outcome
Mitochondrial oxygen consumption (rate of oxygen consumption per milligram of left ventricular tissue)
Time frame: 2016-2020
Mitochondrial respiration in nmol O2/minute/mg of tissue weight will be measured as an indicator of mitochondrial ATP production capacity, using different metabolic substrates
Myocardial production of reactive oxygen species
Time frame: 2016-2020
Myocardial production of reactive oxygen species will be measured using electron paramagnetic resonance and fluorometry
1 secondary outcome
Anti-cardiolipin antibodies in the blood of patients with symptoms of cardiac ischemia
Time frame: 2016-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease and Diabetes Mellitus, run by University of Split, School of Medicine at 1 site in Croatia.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jun 2020. 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 Croatia. 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?
Results are not available in the source record.
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?
Mitochondrial oxygen consumption (rate of oxygen consumption per milligram of left ventricular tissue) (time frame: 2016-2020). The study lists 2 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 19 Jun 2020.