Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181799
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2023-12-13
Brief Title:
Breathome and Single Lead Electrocardiogram Optimizes Ischemic Heart Disease Diagnosis
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
Brief Summary:
This is a prospective case-control single center observational non-randomized study It is carried out to evaluate the diagnostic accuracy of functional tests with physical load under the control of a 12-lead ECG together with analysis of the parameters of volatile organic compounds of the exhaled breath and single-lead ECG data
Detailed Description:
The planned number of participants to include in the study is 80 admitted to the University Clinical Hospitals No 1 at the IM Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation Sechenov University
The study includes the following stages
1 Participants will be selected according to inclusion and exclusion criteria
2 Work with medical documentation
3 Instrumental and laboratory examinations of the participants
31 Analysis of exhaled air will be carried out with the Compact PTR-MS instrument manufactured by Ionicon Austria analytical device registration certificate No C1607C05
32 Cardio ankle vascular index CAVI analysis will be conducted before the physical exertion using the Fukuda Denshi apparatus Japan a microphone for cardio-phonogram measurements fixed with double-sided tape over the sternum in the second intercostal space
33 All the participants will undergo a single blood sampling during the day of performing of the study blood test 10 ml from a peripheral vein to determine the level of total cholesterol low-density lipoprotein LDL very low-density lipoprotein VLDL high-density lipoprotein HDL triglycerides C-reactive protein CRP lipoprotein a apolipoprotein B interleukin-6 IL-6 interleukin-3 IL-3
35 Both groups will perform a bicycle ergometry on SCHILLER device test to evaluate the response to physical activity
36 Before and immediately after the exercise test all patients are scheduled to record a single-lead ECG and pulse wave using a portable single-lead recorder Cardio-Qvark Russia Moscow
46 Computed tomography myocardial perfusion imaging on a CT with 640 slices Canon during stress with Adenosine triphosphate will be performed
After completion of the instrumental and laboratory analysis a statistical analysis will be conducted using classical statistics and artificial intelligence as well as machine learning models
The study includes the following stages
1 Participants will be selected according to inclusion and exclusion criteria
2 Work with medical documentation
3 Instrumental and laboratory examinations of the participants
31 Analysis of exhaled air will be carried out with the Compact PTR-MS instrument manufactured by Ionicon Austria analytical device registration certificate No C1607C05
32 Cardio ankle vascular index CAVI analysis will be conducted before the physical exertion using the Fukuda Denshi apparatus Japan a microphone for cardio-phonogram measurements fixed with double-sided tape over the sternum in the second intercostal space
33 All the participants will undergo a single blood sampling during the day of performing of the study blood test 10 ml from a peripheral vein to determine the level of total cholesterol low-density lipoprotein LDL very low-density lipoprotein VLDL high-density lipoprotein HDL triglycerides C-reactive protein CRP lipoprotein a apolipoprotein B interleukin-6 IL-6 interleukin-3 IL-3
35 Both groups will perform a bicycle ergometry on SCHILLER device test to evaluate the response to physical activity
36 Before and immediately after the exercise test all patients are scheduled to record a single-lead ECG and pulse wave using a portable single-lead recorder Cardio-Qvark Russia Moscow
46 Computed tomography myocardial perfusion imaging on a CT with 640 slices Canon during stress with Adenosine triphosphate will be performed
After completion of the instrumental and laboratory analysis a statistical analysis will be conducted using classical statistics and artificial intelligence as well as machine learning models
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