- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179137
Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium
June 17, 2020 updated by: University of Split, School of Medicine
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Split, Croatia, 21000
- School of Medicine, University of Split
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hemodynamically stable patients with coronary artery disease diagnosed with angiography with indication for coronary artery bypass grafting surgery
Description
Inclusion Criteria:
- Coronary artery disease
- Indication for coronary artery bypass grafting surgery
Exclusion Criteria:
- Emergency patients
- Patients with LV ejection fraction (LVEF) below 30%
- Patients with severe renal, hepatic or pulmonary disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2016-2020
|
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
|
2016-2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-cardiolipin antibodies in the blood of patients with symptoms of cardiac ischemia
Time Frame: 2016-2020
|
Anticardiolipin antibodies assessed in venous blood of patients with angina pectoris undergoing coronary angiography
|
2016-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
May 30, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
June 19, 2020
Last Update Submitted That Met QC Criteria
June 17, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2181-198-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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