Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium

NCT03179137 | Unknown

• 1 other identifier: 2181-198-03
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus; Mitochondrial Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

• 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

• Myocardial production of reactive oxygen species

  Myocardial production of reactive oxygen species will be measured using electron paramagnetic resonance and fluorometry

  2016-2020

Secondary Outcomes (1)

• Anti-cardiolipin antibodies in the blood of patients with symptoms of cardiac ischemia

  2016-2020

Interventions

Standard therapy OTHER

Patients with therapy prescribed independent of the study

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Coronary artery disease
• Indication for coronary artery bypass grafting surgery

You may not qualify if:

• Emergency patients
• Patients with LV ejection fraction (LVEF) below 30%
• Patients with severe renal, hepatic or pulmonary disease

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

School of Medicine, University of Split

Split, 21000, Croatia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human myocardial tissue, atrial and ventricular; Venous blood

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 7, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)