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

October 5, 2021 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Tomsk, Russian Federation, 634000
        • Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 (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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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:

  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

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:

  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

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.
  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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Konstantin Zavadovsky, MD, Cardiology Research Institute, Tomsk National Research Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SciCoRIC
  • АААА-А15-115123110026-3 (Other Identifier: Cardiology Research Institute, Tomsk NRMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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