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

NCT ID: NCT04508608

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-09-01

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.

Conditions

Ischemic Cardiomyopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ischemic cardiomyopathy group - 1 (ICM-1)

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).

Stress Gated blood pool SPECT

Intervention Type: DIAGNOSTIC_TEST

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)

Ischemic cardiomyopathy group - 2 (ICM-2)

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).

Dynamic SPECT

Intervention Type: DIAGNOSTIC_TEST

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)

Control group for GBPS.

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).

Stress Gated blood pool SPECT

Intervention Type: DIAGNOSTIC_TEST

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)

Control group for CFR.

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).

Dynamic SPECT

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Stress radionuclide angiography; Stress radionuclide ventriculography; Radionuclide coronary flow reserve assessement

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konstantin Zavadovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Research Institute, Tomsk National Research Medical Centre

Locations

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

Tomsk, , Russia

Countries

Russia

References

Shipulin VV, Andreev SL, Pryakhin AS, Mochula AV, Maltseva AN, Sazonova SI, Shipulin VM, Massalha S, Zavadovsky KV. Low-dose dobutamine stress gated blood pool SPECT assessment of left ventricular contractile reserve in ischemic cardiomyopathy: a feasibility study. Eur J Nucl Med Mol Imaging. 2022 Jun;49(7):2219-2231. doi: 10.1007/s00259-022-05714-y. Epub 2022 Feb 12.

Reference Type: DERIVED

PMID: 35150293 (View on PubMed)

Other Identifiers

АААА-А15-115123110026-3

Identifier Type: OTHER

Identifier Source: secondary_id

SciCoRIC

Identifier Type: -

Identifier Source: org_study_id