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

NCT04508608 | Completed

• 2 other identifiers: SciCoRICАААА-А15-115123110026-3
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy

Keywords

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

Outcome Measures

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.

  12 month

Study Arms (4)

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

Stress Gated blood pool SPECT 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)

Also known as: Stress radionuclide angiography, Stress radionuclide ventriculography

Control group for GBPS.; Ischemic cardiomyopathy group - 1 (ICM-1)

Dynamic SPECT 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)

Also known as: Radionuclide coronary flow reserve assessement

Control group for CFR.; Ischemic cardiomyopathy group - 2 (ICM-2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)
• B) For GBPS Control group
• Absence of obstructive coronary artery lesion;
• Absence of history of MI and revascularization.
• C) For CFR Control group
• Presence of obstructive coronary artery lesion;
• Indications for coronary artery bypass grafting;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

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

Tomsk, 634000, Russia

Location

Related Publications (1)

• 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.

  PMID: 35150293 DERIVED

Study Officials

• Konstantin Zavadovsky, MD

  Cardiology Research Institute, Tomsk National Research Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)