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

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04508608

Collaborator

(none)

120

Enrollment

Location

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Cardiomyopathy	Diagnostic Test: Stress Gated blood pool SPECT Diagnostic Test: Dynamic SPECT

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 Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Ischemic cardiomyopathy group - 1 (ICM-1) Inclusion criteria: History of myocardial infarction (MI) or revascularization (CABG or PCI); > 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); LV ejection fraction (EF) <40% and increase in LV volumes according to echocardiography (ECHO) Exclusion criteria: Presence of contraindications to the stress test with inotropic stimulation; inflammatory myocardial diseases; the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 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).	Diagnostic Test: Stress Gated blood pool SPECT After labeling of red blood cells in vivo, a sequential series of acquisition is carried out at rest and during increasing doses of dobutamine (5/10/15 μg / kg / min). The duration of acquisition is 300 seconds. The acquisitions are carried out on dedicated cardiac gamma-camera with ultrafast Cadmium zinc telluride (CZT) detectors (DiscoveryNM530c, General electric Healthcare Israel, Israel) Other Names: Stress radionuclide angiography Stress radionuclide ventriculography
Ischemic cardiomyopathy group - 2 (ICM-2) Inclusion criteria: History of myocardial infarction (MI) or revascularization (CABG or PCI); > 75% stenosis of left main or proximal LAD and/ or stenosis of > 75% of ≥2 epicardial vessels (based on coronary angiography (CA) data); LV EF <40% and increase in LV volumes according to echocardiography (ECHO) Exclusion criteria: Presence of contraindications to the stress test with inotropic stimulation; inflammatory myocardial diseases; the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 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).	Diagnostic Test: Dynamic SPECT The passage of a radiopharmaceutical bolus through the cavities of the heart and myocardium at rest and during infusion of adenosine at a dosage of 140 mcg / kg / min (for 4 minutes) is recorded. At the peak of the stress test (after 2 minutes of administration of adenosine), a 5 ml bolus (dose 260-444 MBq) of 99mTc-methoxyisobutylisonitrile (MIBI) is administered at a rate of 1 ml / s. Immediately after the end of tracer administration, 30 ml of 0.9% sodium chloride (NaCl) is infused. A scintigraphic recording of the study begins 5 seconds before the administration of the radiopharmaceutical. The next day, the study at rest is carried out. Scintigraphic images are recorded in tomographic mode with ECG synchronization for 600 s, at list mode. The acquisitions are carried out on dedicated cardiac gamma-camera with ultrafast CZT detectors (DiscoveryNM530c, General electric Healthcare Israel, Israel) Other Names: Radionuclide coronary flow reserve assessement
Control group for GBPS. Inclusion criteria: Absence of obstructive coronary artery lesion; Absence of history of MI and revascularization. Exclusion criteria: Presence of contraindications to the stress test with inotropic stimulation; inflammatory myocardial diseases; the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 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).	Diagnostic Test: Stress Gated blood pool SPECT After labeling of red blood cells in vivo, a sequential series of acquisition is carried out at rest and during increasing doses of dobutamine (5/10/15 μg / kg / min). The duration of acquisition is 300 seconds. The acquisitions are carried out on dedicated cardiac gamma-camera with ultrafast Cadmium zinc telluride (CZT) detectors (DiscoveryNM530c, General electric Healthcare Israel, Israel) Other Names: Stress radionuclide angiography Stress radionuclide ventriculography
Control group for CFR. Presence of obstructive coronary artery lesion; Indications for coronary artery bypass grafting Exclusion criteria: Presence of contraindications to the adenosine stress test; inflammatory myocardial diseases; the presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research; 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).	Diagnostic Test: Dynamic SPECT The passage of a radiopharmaceutical bolus through the cavities of the heart and myocardium at rest and during infusion of adenosine at a dosage of 140 mcg / kg / min (for 4 minutes) is recorded. At the peak of the stress test (after 2 minutes of administration of adenosine), a 5 ml bolus (dose 260-444 MBq) of 99mTc-methoxyisobutylisonitrile (MIBI) is administered at a rate of 1 ml / s. Immediately after the end of tracer administration, 30 ml of 0.9% sodium chloride (NaCl) is infused. A scintigraphic recording of the study begins 5 seconds before the administration of the radiopharmaceutical. The next day, the study at rest is carried out. Scintigraphic images are recorded in tomographic mode with ECG synchronization for 600 s, at list mode. The acquisitions are carried out on dedicated cardiac gamma-camera with ultrafast CZT detectors (DiscoveryNM530c, General electric Healthcare Israel, Israel) Other Names: Radionuclide coronary flow reserve assessement

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

А) For ICM group:

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

For GBPS Control group

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

For CFR Control group

Presence of obstructive coronary artery lesion;
Indications for coronary artery bypass grafting;

Exclusion Criteria (for all groups):

Presence of contraindications to the stress test with inotropic stimulation;
Inflammatory myocardial diseases;
The presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research;
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).