ClinicalTrials.gov
ClinicalTrials.gov Menu

Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients (CCT/MPERF)

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: NCT02361996
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2015
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Medical University of Graz
Graz University of Technology
Information provided by (Responsible Party):
Rainer Rienmueller, M.D., Bakulev Scientific Center of Cardiovascular Surgery

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. Before and after coronary bypass surgery
  2. Before and after coronary vessel dilatation/stenting
  3. 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.

Design:

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
Observational Model: Case-Only
Time Perspective: Prospective
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.
Actual Study Start Date : February 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Change of myocardial perfusion (ml/100g/min) [MPerf] [ Time Frame: 2015 - 2019 ]
    after indication for and before intervention or surgery and after intervention or surgery one day before discharge


Secondary Outcome Measures :
  1. Composition of parameters influencing the complexity of myocardial perfusion regulation: Heart-rate, blood-pressure, rate-pressure-product, left ventricular haemodynamic parameters [ Time Frame: 2015 - 2019 ]
    after indication for and before intervention or surgery and after intervention or surgery one day before discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 -

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): NCT02361996


Locations
Austria
Graz University of Technology
Graz, Austria, 8010
Russian Federation
Bakoulev Scientific Center for Cardiovascular Surgery
Moscow, Russian Federation, 121552
Uzbekistan
Republican Specialized Center of Surgery
Tashkent, Uzbekistan, 100115
Sponsors and Collaborators
Bakulev Scientific Center of Cardiovascular Surgery
Medical University of Graz
Graz University of Technology
Investigators
Study Director: Rainer K Rienmueller, MD Bakoulev Scientific Centre for Cardiovascular Surgery; Medical University Graz
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: Theresa Rienmüller, Dr.techn. Graz University of Technology

Additional Information:
Publications:
Responsible Party: Rainer Rienmueller, M.D., em.Univ.Prof.Dr.med., Bakulev Scientific Center of Cardiovascular Surgery
ClinicalTrials.gov Identifier: NCT02361996     History of Changes
Other Study ID Numbers: RENE271242
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Aortic Valve Stenosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction