Clinical trial NCT04508608: Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
Official title: Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Cardiomyopathy
Keywords: Ischemic Cardiomyopathy
Single photon emission computed tomography
Gated blood pool SPECT
Coronary flow reserve
Prognosis
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being living in Russian Federation (inc.ethnic minorities)

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of patients with an ongoing LV remodeling and reverse LV remodeling.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
Study officials:
affiliation: Cardiology Research Institute, Tomsk National Research Medical Centre
name: Konstantin Zavadovsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.