Ischemic CardiomyopathySciCoRICNCT04508608
Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
An observational study of Ischemic Cardiomyopathy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- Stress Gated blood pool SPECT and Dynamic SPECT
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2018to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being living in Russian Federation (inc.ethnic minorities)
Who may be able to join
- 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;
Show all 10Show fewer
- Absence of history of MI and revascularization.
- For CFR Control group
- Presence of obstructive coronary artery lesion;
- Indications for coronary artery bypass grafting;
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
Tomsk, 634000
About this study
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.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- Stress Gated blood pool SPECT, Dynamic SPECT
- Keywords
- Ischemic Cardiomyopathy, Single photon emission computed tomography, Gated blood pool SPECT, Coronary flow reserve, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Gated blood pool SPECTDiagnostic test
Also called Stress radionuclide angiography, Stress radionuclide ventriculography
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)
Dynamic SPECTDiagnostic test
Also called Radionuclide coronary flow reserve assessement
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Diagnostic Test: Dynamic SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konstantin Zavadovsky, MD, Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508608
- Sponsor's protocol ID
- CRI-178
- Other IDs
- АААА-А15-115123110026-3
- Acronym
- SciCoRIC
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04508608
- Acronym / sponsor ID
- SciCoRIC / CRI-178
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Ischemic Cardiomyopathy, Single photon emission computed tomography, Gated blood pool SPECT, Coronary flow reserve, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ischemic cardiomyopathy group - 1 (ICM-1) | – | Diagnostic Test: Stress Gated blood pool SPECTInclusion 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). |
| Ischemic cardiomyopathy group - 2 (ICM-2) | – | Diagnostic Test: Dynamic SPECTInclusion 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 GBPS. | – | Diagnostic Test: Stress Gated blood pool SPECTInclusion 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). |
| Control group for CFR. | – | Diagnostic Test: Dynamic SPECT1. 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being living in Russian Federation (inc.ethnic minorities)
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Gated blood pool SPECTAlso: Stress radionuclide angiography, Stress radionuclide ventriculographyAfter 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) | Diagnostic test | Control group for GBPS., Ischemic cardiomyopathy group - 1 (ICM-1) |
| Dynamic SPECTAlso: Radionuclide coronary flow reserve assessementThe 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) | Diagnostic test | Control group for CFR., Ischemic cardiomyopathy group - 2 (ICM-2) |
Primary outcome
Number of patients with an ongoing LV remodeling and reverse LV remodeling.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 35150293Shipulin 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.
- Individual participant dataSharing planned: No
Related trials for Ischemic Cardiomyopathy
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantin Zavadovsky, MD principal investigator
Cardiology Research Institute, Tomsk National Research Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with an ongoing LV remodeling and reverse LV remodeling. (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.