Evaluating heart function and blood flow in patients with coronary artery disease

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

This study is trying to see how well the heart works and how blood flows in people with coronary artery disease by using special imaging and stress tests.

Quick facts

• Study type: Observational
• Enrollment: 75 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Tomsk)
• Trial ID: NCT06969547 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess mechanical dyssynchrony of the left ventricle using SPECT imaging in patients with coronary microvascular dysfunction and chronic coronary heart disease. Participants will undergo a two-day protocol involving blood sampling and dynamic SPECT imaging, including a resting phase followed by stress testing with dobutamine. The study will categorize patients based on their myocardial blood flow reserve, providing insights into the relationship between mechanical dyssynchrony and coronary microvascular function.

Who should consider this trial

Good fit: Ideal candidates include patients with ischemia but no obstructive coronary arteries, those with obstructive coronary artery disease, and patients without evidence of coronary heart disease.

Not a fit: Patients with significant heart conditions such as severe left ventricular dysfunction or a history of myocardial infarction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of heart function in patients with coronary artery disease, leading to improved diagnostic and treatment strategies.

How similar studies have performed: While the approach of using SPECT imaging for assessing myocardial blood flow is established, the specific focus on mechanical dyssynchrony in this context may provide novel insights.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where this trial is running

Tomsk

• Tomsk NRMC Cardiology Research Institute — Tomsk, Russia (Recruiting)

Study contacts

• Principal investigator: Vladimir V Shipulin, MD, PhD — Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
• Study coordinator: Vladimir V Shipulin, MD, PhD

Conditions Myocardial Blood Flow Reserve; Mechanical Dyssynchrony; Coronary Arterial Disease; SPECT; gated MPI; mechanical dyssynchrony; dobutamine; myocardial bloow flow reserve