Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium

Coronary Artery Disease Clinical Trial

Official title:

Pathophysiological Mechanisms Elicited by Ischemia and Metabolic Co-morbidities in Myocardium of Patients With Coronary Artery Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03179137
• Other study ID #: 2181-198-03
• Status: Active, not recruiting
• Start date: October 1, 2016
• Est. completion date: October 1, 2021

Study information

• Verified date: June 2020
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: October 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Metabolic Diseases
• Mitochondrial Metabolism Disorders
• Myocardial Ischemia

Intervention

Other:
• Standard therapy
Patients with therapy prescribed independent of the study

Locations

Country	Name	City	State
Croatia	School of Medicine, University of Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2016-2020
Primary	Myocardial production of reactive oxygen species	Myocardial production of reactive oxygen species will be measured using electron paramagnetic resonance and fluorometry	2016-2020
Secondary	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	2016-2020