Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508608
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2020-08-07
Brief Title:
Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study Overview
Official Title:
Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SciCoRIC
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 mcgkgmin 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 51015 μgkgmin 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
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 mcgkgmin 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 51015 μgkgmin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| АААА-А15-115123110026-3 | OTHER | Cardiology Research Institute Tomsk NRMC | None |