An interventional study of Dimethyl Malonate and Ischemic preconditioning in Reperfusion Injuries, Myocardial, sponsored by University of Aarhus. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
The overall aim of this study is to examine the role of mitochondrial respiration in human diabetic tissue before and after ischemia. Furthermore we will examine the ability of ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic performance of both non-diabetic and diabetic fibers after ischemia. To increase our understanding on the metabolic changes during ischemia in both non-diabetic and diabetic tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic mitochondrial respiration.
20 diabetic and 20 non-diabetic patients undergoing elective CABG surgery or other heart surgery where extracorporal circulation is used will be included in the study. The patiens will not be given any treatment prior to the operation. During the cardiac surgery a small sample of the heart is routinely removed when the patient is connection to the heart-lung machine. From this tissue sample it is possible to isolate muscle trabeculae which will be used in an atrial strip model and randomized to one of four types of treatment. Simultaneously with the isolation of the trabeculae, a fifth trabecular will be used to assess mitochondrial respiration at baseline. Group 1 will serve as a sham control, group 2 will serve as ischemic control and receive an extended period of hypoxia, Group 3 will be treated with ischemic preconditioning, where short periods of non lethal lack of oxygen will be given directly to the tissue (after removal from the patient) prior to the extended period of hypoxia, Group 4 will receive dimethyl malonate prior to the prolonged hypoxia.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's enrollment of 39 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Heart tissue obtained from non-diabetic patients undergoing surgery will not receive drugs or ischemia
Other: Sham
Heart tissue from non-diabetic patients undergoing surgery will not receive drugs but will receive ischemia
Other: Ischemia reperfusion
Heart tissue from non-diabetic patients undergoing surgery will not receive drugs but will receive short periods of ischemia prior to index ischemia
Biological: Ischemic preconditioning
Heart tissue from non-diabetic patients undergoing surgery will receive a drug (Dimethyl Malonate) prior to index ischemia
Drug: Dimethyl Malonate
Heart tissue obtained from diabetic patients undergoing surgery will not receive drugs or ischemia
Other: Sham
Heart tissue from diabetic patients undergoing surgery will not receive drugs but will receive ischemia
Other: Ischemia reperfusion
Heart tissue from diabetic patients undergoing surgery will not receive drugs but will receive short periods of ischemia prior to index ischemia
Biological: Ischemic preconditioning
Heart tissue from diabetic patients undergoing surgery will receive a drug (Dimethyl Malonate) prior to index ischemia
Drug: Dimethyl Malonate
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Also known as: Dimethyl Malonate; PubChem Substance ID 24848281
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Mitochondrial respiration of individual complexes
Mitochondrial respiration of individual complexes will serve as primary outcome and will be examined by oxygraph technique.
Time frame: Outcome will be assessed within a year when the inclusion of patients is complete
Hemodynamic performance
Hemodynamic performance will be measured as contractile force of heart fibers before during and after ischemia.
Time frame: Outcome will be assessed within a year when the inclusion of patients is complete
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Aarhus