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CompletedNCT04508608SciCoRICUpdated Jun 26, 2026

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

An observational study in Ischemic Cardiomyopathy, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Completed at 1 site in Russia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Cardiomyopathy

Keywords

  • Ischemic Cardiomyopathy
  • Single photon emission computed tomography
  • Gated blood pool SPECT
  • Coronary flow reserve
  • Prognosis
03

In context

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients being living in Russian Federation (inc.ethnic minorities)

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

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).
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

    Diagnostic Test: Stress Gated blood pool SPECT

  • 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).

    Diagnostic Test: Dynamic SPECT

  • 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).

    Diagnostic Test: Stress Gated blood pool SPECT

  • 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).

    Diagnostic Test: Dynamic SPECT

Interventions

  • Diagnostic testStress 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)

    Also known as: Stress radionuclide angiography, Stress radionuclide ventriculography

  • Diagnostic testDynamic 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)

    Also known as: Radionuclide coronary flow reserve assessement

06

What researchers measure

Primary outcomes

  1. Number of patients with an ongoing LV remodeling and reverse LV remodeling.

    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.

    Time frame: 12 month

07

Study locations

1 site
  • Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
    Tomsk, 634000, Russia
08

References and documents

Publications

  • 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. PubMed 35150293 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04508608
Lead sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Responsible party
Sponsor
First posted
Aug 11, 2020
Start date
Sep 1, 2018
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Jun 26, 2026

Study contacts

Konstantin Zavadovsky, MD
principal investigator · Cardiology Research Institute, Tomsk National Research Medical Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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