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

Conditions

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

  • Croatia
      • Split, Croatia, 21000
        • School of Medicine, University of Split

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.

Sponsor

University of Split, School of Medicine

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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