Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy

Completed

• Conditions: Ischemic Cardiomyopathy
• Interventions: Diagnostic Test: Stress Gated blood pool SPECT; Diagnostic Test: Dynamic SPECT

• Registration Number: NCT04508608
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

According to single-photon emission computed tomography, the left ventricular contractile and coronary flow reserve (CFR) will be assessed in patients with ischemic cardiomyopathy. According to these data, the criteria for predicting the effectiveness of complex surgical treatment of this pathology will be evaluated.

Detailed Description

Before surgical intervention, all patients pass routine clinical analyzes undergo coronary angiography and 2D echocardiography. Some of patients in the ICM-1 and ICM-2 groups undergo stress echocardiography with dobutamine.

Coronary arteriography is performed using the Axiom Artis (Siemens; Erlangen, Germany) and transthoracic two-dimensional Doppler echocardiography (TTE) with the Acuson Sequoia 512 (Siemens; Erlangen, Germany)).

Besides, all of the ICM-1 and ICM-2 groups patients undergo myocardial perfusion imaging. Standard two-day stress-rest imaging protocol is used. Adenosine at a dosage of 140 mcg/kg/min (for 4 min) is used as a pharmaceutical stress agent.

ICM-1 group and Control group for GBPS undergo gated blood pool SPECT (GBPS) at rest and during increasing doses of dobutamine (5/10/15 μg/kg/min) (n = 60) ICM-2 group and Control group for CFR undergo dynamic SPECT (n = 40). This investigation is combined with routine myocardial perfusion imaging so patients are not exposed to extra stress.

Than ICM patients undergo surgical treatment of ICM in different volume. All of them receive coronary bypass grafting (CABG); some patients undergo the left ventricular reconstruction and intervention on the mitral valve.

In the early postoperative period (7-14 days), the ICM-1 group undergo rest GBPS and ICM-2 group undergo dynamic SPECT by two-day protocol. All patients undergo TTE too.

After at least 12 month, all patients undergo TTE to assess the presence of left ventricular (LV) remodeling.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Status Verified: 2020-10
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

А) For ICM group:

1. History of myocardial infarction (MI) or revascularization (CABG or PCI);
2. > 75% stenosis of left main or proximal LAD and/ or stenosis of > 75% of ≥2 epicardial vessels (based on coronary angiography (CA) data);
3. LV EF <40% and increase in LV volumes according to echocardiography (ECHO)

B) For GBPS Control group

1. Absence of obstructive coronary artery lesion;
2. Absence of history of MI and revascularization.

C) For CFR Control group

1. Presence of obstructive coronary artery lesion;
2. Indications for coronary artery bypass grafting;

Exclusion Criteria (for all groups):

1. Presence of contraindications to the stress test with inotropic stimulation;
2. Inflammatory myocardial diseases;
3. The presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research;
4. Life expectancy of less than 6 months (acute renal and hepatic failure, mental illness, malignant neoplasms of the final stages, unsuitable correction of brain injury).

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ischemic cardiomyopathy group - 1 (ICM-1)	Stress Gated blood pool SPECT	Inclusion criteria: 1. History of myocardial infarction (MI) or revascularization (CABG or PCI); 2. \> 75% stenosis of left main or proximal left anterior descending artery (LAD) and/ or stenosis of \> 75% of ≥2 epicardial vessels (based on coronary angiography (CA) data); 3. LV ejection fraction (EF) \<40% and increase in LV volumes according to echocardiography (ECHO) Exclusion criteria: 1. Presence of contraindications to the stress test with inotropic stimulation; 2. inflammatory myocardial diseases; 3. the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 4. life expectancy of less than 6 months (acute renal and hepatic failure, mental illness, malignant neoplasms of the final stages, unsuitable correction of brain injury).
Control group for GBPS.	Stress Gated blood pool SPECT	Inclusion criteria: 1. Absence of obstructive coronary artery lesion; 2. Absence of history of MI and revascularization. Exclusion criteria: 1. Presence of contraindications to the stress test with inotropic stimulation; 2. inflammatory myocardial diseases; 3. the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 4. life expectancy of less than 6 months (acute renal and hepatic failure, mental illness, malignant neoplasms of the final stages, unsuitable correction of brain injury).
Ischemic cardiomyopathy group - 2 (ICM-2)	Dynamic SPECT	Inclusion criteria: 1. History of myocardial infarction (MI) or revascularization (CABG or PCI); 2. \> 75% stenosis of left main or proximal LAD and/ or stenosis of \> 75% of ≥2 epicardial vessels (based on coronary angiography (CA) data); 3. LV EF \<40% and increase in LV volumes according to echocardiography (ECHO) Exclusion criteria: 1. Presence of contraindications to the stress test with inotropic stimulation; 2. inflammatory myocardial diseases; 3. the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 4. life expectancy of less than 6 months (acute renal and hepatic failure, mental illness, malignant neoplasms of the final stages, unsuitable correction of brain injury).
Control group for CFR.	Dynamic SPECT	1. Presence of obstructive coronary artery lesion; 2. Indications for coronary artery bypass grafting Exclusion criteria: 1. Presence of contraindications to the adenosine stress test; 2. inflammatory myocardial diseases; 3. the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 4. life expectancy of less than 6 months (acute renal and hepatic failure, mental illness, malignant neoplasms of the final stages, unsuitable correction of brain injury).

Primary Outcome Measures

Name	Time	Method
Number of patients with an ongoing LV remodeling and reverse LV remodeling.	12 month	Ongoing LV remodeling is meant increase of LV end-systolic volume (LVESV) or decrease of LVESV≤10% according to 2D echocardiography in comparison to early postoperative period study. Reverse LV remodeling is meant decrease in LVESV \>10% according to 2D echocardiography in comparison to early postoperative period study.

Trial Locations

Locations (1)

Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences; 🇷🇺 Tomsk, Russian Federation