Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT

NCT06969547 | Recruiting

• 1 other identifier: 249
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The project is aimed at studying the feasibility of mechanical dyssynchrony of the left ventricle of the heart, determined by SPECT (gated MPI), as well as its stress-induced dynamics, in the evaluation of patients with coronary microvascular dysfunction in chronic coronary heart diseasу.

Conditions

Myocardial Blood Flow Reserve; Mechanical Dyssynchrony; Coronary Arterial Disease (CAD)

Keywords

SPECT; gated MPI; mechanical dyssynchrony; dobutamine; myocardial bloow flow reserve

Outcome Measures

Primary Outcomes (1)

• Decreased myocardial blood flow reserve

  Baseline decrease in myocardial blood flow reserve according to dynamic SPECT \<2.0

  1 day

Study Arms (3)

Ischemia with no obstructive coronary arteries (INOCA)

Patients with suspected chronic coronary heart disease and non-obstructive coronary artery disease according to CT coronary angiography

Diagnostic Test: dynamic SPECT (two-day rest/stress protocol); Diagnostic Test: gated myocardial perfusion imaging; Other: blood sampling; Diagnostic Test: Low Dose CT-scan; Diagnostic Test: CT-coronary angiography

Obstructive coronary artery disease (CAD)

Patients with chronic coronary heart disease and significant (\>50%) lesion of one or more coronary artery according to CT coronary angiography

Diagnostic Test: dynamic SPECT (two-day rest/stress protocol); Diagnostic Test: gated myocardial perfusion imaging; Other: blood sampling; Diagnostic Test: Low Dose CT-scan; Diagnostic Test: CT-coronary angiography

Control

Patients without evidence of coronary heart disease

Diagnostic Test: dynamic SPECT (two-day rest/stress protocol); Diagnostic Test: gated myocardial perfusion imaging; Other: blood sampling; Diagnostic Test: Low Dose CT-scan

Interventions

dynamic SPECT (two-day rest/stress protocol) DIAGNOSTIC_TEST

All nuclear examinations will be performed using a hybrid specialized SPECT/CT Discovery NM/CT570C. At the first stage the passage of the bolus of the radiopharmaceutical through the chambers and the LV myocardium will be recorded at rest. Through a pre-installed intravenous catheter, a bolus of the radiopharmaceutical in a volume of 5 ml (370 MBq) will be injected at a rate of 0,5 ml/sec, after which 30 ml of saline will be injected at a rate of 2 ml/sec. Data acquisition will begin immediately before the introduction of the radiopharmaceutical. Registration of dynamic images will be performed in the "List Mode". At the second day stress test study will be performed (ATP at a dosage of 160 mcg/kg/min over 4 minutes). The bolus volume of the radiopharmaceutical, saline and the rate are equal to the study at rest. The time of data collection at each stage of the study will be 12 minutes. The introduction of the radiopharmaceutical will be performed at 2 minutes of the stress test.

Control; Ischemia with no obstructive coronary arteries (INOCA); Obstructive coronary artery disease (CAD)

gated myocardial perfusion imaging DIAGNOSTIC_TEST

Gated MPI will be performed according to a two-day rest-stress protocol. For both stress and rest studies, the acquisition will be performed 60 minutes after the dynamic SPECT. The recording time will be 5 minutes. To correct the attenuation, a low-dose CT scan of the chest, obtained earlier with dynamic recording, will be used. The voltage on the X-ray tube will be 120 kV, the current strength will be 20 mA; tube rotation time 0.8 s; pitch 0.969:1. Radiopharmaceutical administration will be performed only once a day during dynamic SPECT. Immediately after recording the gMPI at rest, the patient will undergo a series of sequential injections of dobutamine at doses of 5 and 10 µg/kg/min with simultaneous recording. The duration of data collection on each dose of dobutamine will be 5 minutes.

Control; Ischemia with no obstructive coronary arteries (INOCA); Obstructive coronary artery disease (CAD)

blood sampling OTHER

Indicators of: * endothelial dysfunction (specific endothelial cell molecule 1 (endocan, ESM1), endotelin-1) * severity of inflammatory response (tumor necrosis factor (TNF-α), interleukin-6 (IL-6)) * myocardial fibrosis (matrix metalloproteinase (MMP-9) * myocardial dysfunction (NT-proBNP)

Control; Ischemia with no obstructive coronary arteries (INOCA); Obstructive coronary artery disease (CAD)

Low Dose CT-scan DIAGNOSTIC_TEST

Scanning parameters: tube voltage 120 kV; current 435 mA; tube rotation time 0.4 s; slice thickness 2.5 mm; interslice interval 2.5 mm.

Control; Ischemia with no obstructive coronary arteries (INOCA); Obstructive coronary artery disease (CAD)

CT-coronary angiography DIAGNOSTIC_TEST

The study will be performed on a 64-slice GE Discovery NM/CT 570С (GE Healthcare, Milwaukee, WI, USA) from the level of the tracheal bifurcation to the diaphragm during breath holding (6-8 s) in the prospective (for HR≤55) or retrospective (for HR\>55) ECG-synchronized mode. To contrast coronary arteries, it is planned to use an intravenous infusion of 85-90 ml (at a rate of 5 ml/s) of an iodine-containing (370 mg iodine/ml) radiopaque substance.Scan will be performed with the following parameters: current strength 120 kV; voltage 300-600 mA with ECG modulation; tube rotation speed 0.4 s; pitch: 0.18-0.22 (depending on heart rate).

Ischemia with no obstructive coronary arteries (INOCA); Obstructive coronary artery disease (CAD)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of Tomsk, Russia

You may qualify if:

• Ischemia with no obstructive coronary arteries (INOCA)
• Obstructive coronary artery disease (CAD)
• Patients without evidence of coronary heart disease

You may not qualify if:

• Left ventricular ejection fraction \<55% according to echocardiography;
• History of myocardial infarction/revascularization;
• hypertension: systolic blood pressure \>180 mm Hg. Art., diastolic BP\>110 mm Hg. Art.;
• systolic arterial hypotension \<80 mm Hg. Art.;
• atrial fibrillation;
• AV blockade of the III degree; sick sinus syndrome;
• massive pulmonary embolism (PE) with a high degree of pulmonary hypertension;
• the presence of significant valvular pathology (mitral insufficiency ≥ 3 degrees, aortic insufficiency ≥ 3 degrees, tricuspid regurgitation ≥ 3 degrees).
• severe course of bronchial asthma, chronic obstructive pulmonary disease;
• decompensated type 2 diabetes,
• severe liver or kidney failure (glomerular filtration rate \<50 ml/min/1.73 m3 (CKD-EPI),
• morbid obesity (body mass index \>45);
• history of myocarditis
• indications of poor drug tolerance;
• oncological diseases;

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• Russian Science Foundation: collaborator

Study Sites (1)

Tomsk NRMC Cardiology Research Institute

Tomsk, 634012, Russia

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection; Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Vladimir V Shipulin, MD, PhD

  Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir V Shipulin, MD, PhD

CONTACT

+79521575263; shipartphoto@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 14, 2025
• Study Start: October 1, 2023
• Primary Completion: May 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)