Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients (CCT/MPERF)
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|ClinicalTrials.gov Identifier: NCT02361996|
Recruitment Status : Unknown
Verified February 2015 by Rainer Rienmueller, M.D., Bakulev Scientific Center of Cardiovascular Surgery.
Recruitment status was: Not yet recruiting
First Posted : February 12, 2015
Last Update Posted : February 12, 2015
It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion. In order to increase (normalize) the reduced perfusion, when conventional approach failed, coronary bypass surgery, coronary vessel dilatation/stenting are performed. The similar situation with reduced myocardial perfusion may be found in patients with stenosis of the aortic valve, where aortic valve replacement may increase myocardial perfusion by left-ventricular remodelling. However, there is presently no method established to measure myocardial perfusion quantitatively and noninvasively before and after a therapeutic intervention.
Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in ml/100g/min would strengthen the indication for specific therapeutic approach and enable an objective control of effectiveness of the applied therapy.
There is a measureable difference in quantitative myocardial perfusion values before (lower) and after (higher) interventional or surgical procedure.
The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT 256 Brilliance ) quantitatively in ml/100g/min in three groups of patients:
- Before and after coronary bypass surgery
- Before and after coronary vessel dilatation/stenting
- Before and after aortic valve replacement.
The investigators will not assign specific interventions to the subjects of these three groups. Therefore, the research is strictly observational.
Prospective study to measure quantitatively myocardial perfusion in the above mentioned three groups of patients with simultaneous control and registration of all essential, physiological determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial perfusion measurements will be performed directly after the indication for intervention or surgery and on the last day before discharge from hospital.
All the collected data (determinants) inclusively the CT-studies will be anonymised and archived on a local server. The investigators of the University of Medical Computed Sciences and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion measurements and all statistical analysis independently of the CT-studies performing physicians.
|Condition or disease|
|Coronary Disease Aortic Valve Stenosis|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||690 participants|
|Official Title:||Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients Before and After Coronary-bypass-surgery, Before and After Dilating/Stenting and Before and After Aortic-valve-replacement.|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2017|
Coronary Bypass Surgery
Aortic Valve Replacement
- Change of myocardial perfusion (ml/100g/min) [MPerf] [ Time Frame: after indication for and before intervention or surgery and after intervention or surgery one day before discharge ]
- Composition of parameters influencing the complexity of myocardial perfusion regulation: Heart-rate, blood-pressure, rate-pressure-product, left ventricular haemodynamic parameters [ Time Frame: after indication for and before intervention or surgery and after intervention or surgery one day before discharge ]
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): NCT02361996
|Contact: Rainer K Rienmueller, MDfirstname.lastname@example.org|
|Bakoulev Scientific Center for Cardiovascular Surgery||Not yet recruiting|
|Moscow, Russian Federation, 121552|
|Contact: Rainer K Rienmueller, MD 0043-664-4225931 email@example.com|
|Contact: Vladimir N Makarenko, MD 007-495-7902352 firstname.lastname@example.org|
|Sub-Investigator: Inna Rychina, MD|
|Republican Specialized Center of Surgery||Not yet recruiting|
|Tashkent, Uzbekistan, 100115|
|Contact: Marat Khodjibekov, MD 00998-71-2772765 email@example.com|
|Contact: Muzaffar F Maksudov, MD 00998-98-361-69-64 firstname.lastname@example.org|
|Sub-Investigator: Muzaffar F Maksudov, MD|
|Study Director:||Rainer K Rienmueller, MD||Bakoulev Scientific Centre for Cardiovascular Surgery, Moscow / Russia; Medical University of Graz / Austria|
|Principal Investigator:||Vladimir N Makarenko, MD||Bakoulev Scientific Centre for Cardiovascular Surgery, Moscow / Russia|
|Principal Investigator:||Marat Khodjibekov, MD||Republican Special Center of Surgery, Tashkent / Uzbekistan|
|Principal Investigator:||Christian Baumgartner, Dr.techn.||University for Medical Computer Sciences and Technology, Innsbruck / Austria|