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

Ischemic Cardiomyopathy Clinical Trial

— SciCoRIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508608
• Other study ID #: SciCoRIC
• Secondary ID: ????-?15-1151231
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2020
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

?) 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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Intervention

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)
• 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)

Locations

Country	Name	City	State
Russian Federation	Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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