Ignite Creation Date:
2024-05-06 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03507270
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2017-05-22
Brief Title:
One-hour Diagnostic Algorithm for NSTEMI
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:
One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Predictable values of the 1-hour algorithm for estimating the concentration of troponin using highly sensitive reagents are 98-100 for excluding myocardial infarction MI and 75-80 for identifying this pathology Such algorithms are developed for the rapid confirmation or exclusion of myocardial infarction without ST-segment elevation and when combined with clinical data and electrocardiogram are used to assess the risk of adverse course of disease and to contribute to decision making about expediency of stay in the intensive therapy unit and early discharge
In mid-1980s a new marker of myocardial damage was proposed namely fatty-acid-binding protein FABP However the diagnostic value of FABP cannot be interpreted unambiguously because of insufficient number of studies determining the sensitivity and specificity of the test in various manifestations of acute coronary syndrome ACS
Available literature presents a wide range of reference values of FABP for MI diagnosis Reference value ranges are proposed by manufacturers of diagnostic kits based on previous studies In addition there is no information about the FABP changes during the first three hours of the disease as well as there are no data on diagnostic value of changes in this indicator in patients with ACS without ST-segment elevation These considerations provide rationale and support novelty of the planned pilot study
In mid-1980s a new marker of myocardial damage was proposed namely fatty-acid-binding protein FABP However the diagnostic value of FABP cannot be interpreted unambiguously because of insufficient number of studies determining the sensitivity and specificity of the test in various manifestations of acute coronary syndrome ACS
Available literature presents a wide range of reference values of FABP for MI diagnosis Reference value ranges are proposed by manufacturers of diagnostic kits based on previous studies In addition there is no information about the FABP changes during the first three hours of the disease as well as there are no data on diagnostic value of changes in this indicator in patients with ACS without ST-segment elevation These considerations provide rationale and support novelty of the planned pilot study
Detailed Description:
After enrollment in the study patients will undergo the following procedures
1 Physical examination at baseline and monitoring of vital signs blood pressure heart rate breathing rate at hours 1 2 and 3 after admission to hospital
2 Registration of 12-lead electrocardiogram ECG at baseline after 24 hours and at the day of discharge
3 At baseline at the time of admission to hospital venous blood will be obtained to perform blood tests for determination of troponin I FABP and CPK-MB levels At the same time venous blood will be sampled for routine clinical laboratory blood tests At hours 1 2 and 3 after admission to hospital venous blood will be sampled for assessment of the troponin I and FABP levels
4 Echocardiography will be performed 24 hours after admission LVEDV LVESV and EF At day 3 standard echocardiography will be performed
1 Physical examination at baseline and monitoring of vital signs blood pressure heart rate breathing rate at hours 1 2 and 3 after admission to hospital
2 Registration of 12-lead electrocardiogram ECG at baseline after 24 hours and at the day of discharge
3 At baseline at the time of admission to hospital venous blood will be obtained to perform blood tests for determination of troponin I FABP and CPK-MB levels At the same time venous blood will be sampled for routine clinical laboratory blood tests At hours 1 2 and 3 after admission to hospital venous blood will be sampled for assessment of the troponin I and FABP levels
4 Echocardiography will be performed 24 hours after admission LVEDV LVESV and EF At day 3 standard echocardiography will be performed
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