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Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03179137
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Split, School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Diabetes Mellitus Mitochondrial Metabolism Disorders Other: Standard therapy

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pathophysiological Mechanisms Elicited by Ischemia and Metabolic Co-morbidities in Myocardium of Patients With Coronary Artery Disease
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Human myocardial tissue, atrial and ventricular; Venous blood


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179137


Locations
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Croatia
School of Medicine, University of Split
Split, Croatia, 21000
Sponsors and Collaborators
University of Split, School of Medicine
  Study Documents (Full-Text)

Documents provided by University of Split, School of Medicine:
Study Protocol  [PDF] June 16, 2017

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Responsible Party: University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03179137    
Other Study ID Numbers: 2181-198-03
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases