Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients

NCT02361996 | Suspended DMC

• 1 other identifier: RENE271242
• Study Type: observational
• Target: 690
• Locations: 3 countries
• Sites: 3

Brief Summary

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 a conventional approach failed, coronary bypass surgery, coronary vessel dilatation or 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. Hypothesis: 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:

1. 1.Before and after coronary bypass surgery
2. 2.Before and after coronary vessel dilatation/stenting
3. 3.Before and after aortic valve replacement.

Conditions

Coronary Disease; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Change of myocardial perfusion (ml/100g/min) [MPerf]

  after indication for and before intervention or surgery and after intervention or surgery one day before discharge

  2015 - 2019

Secondary Outcomes (1)

• Composition of parameters influencing the complexity of myocardial perfusion regulation: Heart-rate, blood-pressure, rate-pressure-product, left ventricular haemodynamic parameters

  2015 - 2019

Study Arms (3)

Coronary Bypass Surgery

inclusion criteria: * presence of at least one coronary stenotic lesion above 50% with clinical indication for coronary bypass surgery. * list of medication timely related to the procedure * signed informed consent exclusion criteria: * intolerance to contrast agent * multiple myeloma, pheochromocytoma, thyroid dysfunction, acute infection * renal failure * severe arrhythmia * pregnancy * reduction of cognitive capabilities to understand the purpose and the extent of the study * participation in a medical-scientific study using X-rays in the last ten years * lack of Russian knowledge to fill the forms * lack of signed study agreement

Coronary Stenting

inclusion criteria: * presence of at least one coronary stenotic lesion above 50% with clinical indication for coronary vessel dilatation/stenting. * list of medication timely related to the procedure * signed informed consent exclusion criteria: * intolerance to contrast agent * multiple myeloma, pheochromocytoma, thyroid dysfunction, acute infection * renal failure * severe arrhythmia * pregnancy * reduction of cognitive capabilities to understand the purpose and the extant of the study * participation in a medical-scientific study using X-rays in the last ten years * lack of Russian knowledge to fill the forms * lack of signed study agreement

Aortic Valve Replacement

inclusion criteria: * presence of aortic valve disease (stenosis) with clinical indication for aortic valve replacement without coronary vessel stenosis above 50% * list of medication timely related to the procedure * signed informed consent exclusion criteria: * intolerance to contrast agent * multiple myeloma, pheochromocytoma, thyroid dysfunction, acute infection * renal failure * severe arrhythmia * pregnancy * reduction of cognitive capabilities to understand the purpose and the extent of the study * participation in a medical-scientific study using X-rays in the last ten years * lack of Russian knowledge to fill the forms * lack of signed study agreement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients above 18 years of age, who are reffered with suspected or known coronary artery disease or aortic valve stenosis either to the Bakoulev Scientific Centre for Cardiovascular Surgery, Moscow / Russia or to the Republican Special Centre of Surgery, Tashkent / Uzbekistan and fulfill the eligibility criteria.

You may qualify if:

• in cohort: Coronary Bypass Surgery:
• o presence of at least one coronary stenotic lesion above 50% with clinical indication for coronary bypass surgery
• in cohort: Coronary Stenting: o presence of at least one coronary stenotic lesion above 50% with indication for coronary vessel dilatation/stenting
• in cohort: Aortic Valve Replacement
• o presence of aortic valve disease (stenosis) with clinical indication for aortic valve replacement without coronary vessel stenosis above 50%
• for all three cohorts:
• list of medication timely related to the procedure
• signed informed consent

You may not qualify if:

• for all three cohorts:
• intolerance to contrast agent
• multiple myeloma, pheochromocytoma, thyroid dysfunction, acute infection
• renal failure
• severe arrhythmia
• pregnancy
• reduction of cognitive capabilities to understand the purpose and the extent of the study
• participation in a medical-scientific study using X-rays in the last ten years
• lack of Russian knowledge to fill the forms
• lack of signed study agreement -

Sponsors & Collaborators

• Bakulev Scientific Center of Cardiovascular Surgery: lead
• Medical University of Graz: collaborator
• Graz University of Technology: collaborator

Study Sites (3)

Graz University of Technology

Graz, 8010, Austria

Location

Bakoulev Scientific Center for Cardiovascular Surgery

Moscow, 121552, Russia

Location

Republican Specialized Center of Surgery

Tashkent, 100115, Uzbekistan

Location

Related Publications (2)

• Rienmuller T, Baumgartner C, Handler M, Makarenko V, Ourednicek P, Krestinich IM, Zhorzholiani ST, Rienmuller R, Bockeria L. Quantitative Estimation of Left Ventricular Myocardial Perfusion Based on Dynamic CT Scans. Biomed Tech (Berl). 2013 Aug;58 Suppl 1:/j/bmte.2013.58.issue-s1-L/bmt-2013-4288/bmt-2013-4288.xml. doi: 10.1515/bmt-2013-4288. Epub 2013 Sep 7. No abstract available.

  PMID: 24042936 BACKGROUND

• Lara-Hernandez A, Rienmuller T, Juarez I, Perez M, Reyna F, Baumgartner D, Makarenko VN, Bockeria OL, Maksudov M, Rienmuller R, Baumgartner C. Deep Learning-Based Image Registration in Dynamic Myocardial Perfusion CT Imaging. IEEE Trans Med Imaging. 2023 Mar;42(3):684-696. doi: 10.1109/TMI.2022.3214380. Epub 2023 Mar 2.

  PMID: 36227828 DERIVED

Related Links

• Bakoulev Scientific Center's Site
• Site of Graz University of Technology

MeSH Terms

Conditions

Coronary Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Rainer K Rienmueller, MD

  Bakoulev Scientific Centre for Cardiovascular Surgery; Medical University Graz

  STUDY DIRECTOR

• 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

• Theresa Rienmüller, Dr.techn.

  Graz University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: em.Univ.Prof.Dr.med.

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

UZ (1); RU (1); AU (1)