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临床试验/NCT06969547
NCT06969547招募中不适用

Evaluation the Capabilities of Cardiac Mechanical Dyssynchrony in the Diagnosis of Myocardial Microvascular Dysfunction in Chronic Ischemic Heart Disease

Tomsk National Research Medical Center of the Russian Academy of Sciences1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
Decreased myocardial blood flow reserve

研究概览

简要总结

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.

详细描述

Each patient will have a peripheral catheter placed, blood will be drawn, followed by dynamic SPECT on a two-day rest/stress protocol, and then standard gated myocardial perfusion scintigraphy will be performed (the resting study will be followed by a study with dobutamine administration at doses of 5 and 10 µg/kg/min). The protocols will be described in detail in the Interventions section. Based on the results of dynamic SPECT, patients will be divided into 2 groups depending on the state of myocardial blood flow reserve. All nuclear examinations will be performed using a hybrid specialized SPECT/CT Discovery NM/CT570C.

  1. Determination of myocardial blood flow and reserve. Myocardial blood flow and reserve will be assessed using specialized software (GE Alcyone: Dynamic Analysis Tool), two series of images will be formed from the array of primary data: 1) reflecting the passage of the radiopharmaceutical bolus through the LV cavity and myocardium from 1 to 120 seconds of the study; 2) a group of 8 dynamic tomoscintigrams (frame duration 30 s) a series of static tomoscintigrams showing the accumulation of the radiopharmaceutical in the LV walls. The next stage of data processing (bi means of of specialized software (4DM CFR) will include the analysis of static and dynamic images, with the establish of "activity-time" graphs based on areas of interest corresponding to the cavity, walls (anterior, posterior, lateral , septum and apex) and 17 segments of the polar map of the left ventricle. On the basis of the obtained graphs, indices of myocardial blood flow at rest and stress will be determined (in ml per 1 gram of tissue per minute) on the basis of which the indices of the reserve of myocardial blood flow will be determined, reflecting the MBF stress/rest ratio. These indices will be estimated for all walls, vascular regions and segments of the polar map of the left ventricle.
  2. Evaluation of myocardial perfusion. To evaluate the results of myocardial perfusion, a specialized software package Corridor 4DM (University of Michigan, Ann Arbor, MI, USA) will be used with the construction of sections along the short and long axes of the heart, as well as a 17-segment polar map of the left ventricle normalized to 100%. Semi-quantitative calculation of local disorders of LV perfusion will be performed in points as follows: 0 - accumulation of radiopharmaceuticals in the myocardial segment ≥70% of the maximum; 1 - a mild decrease in accumulation (50-69%), 2 - a moderately reduced accumulation (30-49%), 3 - a pronounced decrease in accumulation (10-29%) and 4 - a severe decrease of radiopharmaceuticals accumulation (<10%). The calculation of the total violation of LV perfusion will be made as follows: a decrease <4 points will be regarded as the norm; 4-8 - as easy; 9-13 - as moderate; >13 - as a severe deterioration of myocardial perfusion. Thus, the total perfusion impairment on exercise (SSS - Summed Stress Score), at rest (SRS - Summed Rest Score), as well as SDS - Summed Difference Score - will be calculated. In addition, the indicator called transient ischemic dilatation (TID) will be determined in a specialized Quantitative Perfusion SPECT software package (QPS software, version 2013, Cedars-Sinai).
  3. Evaluation of inotropic function and mechanical dyssynchrony

To assess contractile dysfunction, we will analyze the results of gMPI obtained during dynamic acquisition with ATP (early post-exercise images), after 60 minutes after the introduction of radiopharmaceuticals, obtained with dobutamine gMPI, as well as during the study at rest. The assessment of stress-induced changes will be estimated as the difference between the score during the stress test and at rest (Δ = [value at stress] - [value at rest]). To get early post-exercise images from the array of primary data obtained during dynamic SPECT, list data from 4 to 8 will be reconstructed. The resulting images will be processed in Corridor 4DM SPECT (INVIA, Ann Arbor, MI, USA), Emory Cardiac Toolbox (Emory University/ Syntermed, Atlanta, GA), and QGS/QPS (Cedars-Sinai Medical Center, CA, USA). After construction the activity-time curve, the following parameters of the LV contractile function will be automatically estimated:

End-systolic volume (ESV, ml); End-diastolic volume (EDV, ml); Ejection fraction (EF, %); Peak ejection rate (PER, EDV/s); Peak filling rate (PFR, EDV/s).

After the construction of the phase histogram according to the algorithm "time to the maximum contraction", the following MD indices will be estimated automatically:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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;
  • chronic alcoholism, mental disorders;
  • other severe comorbidity,
  • refusal to participate in the study.

结局指标

主要结局

Decreased myocardial blood flow reserve

时间窗: 1 day

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vladimir Shipulin

Dr.

Tomsk National Research Medical Center of the Russian Academy of Sciences

研究点 (1)

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