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One-hour Diagnostic Algorithm for NSTEMI

Primary Purpose

Non ST Segment Elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
FABP
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non ST Segment Elevation Myocardial Infarction focused on measuring FABP, non ST Segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-80 years old
  • Male patients
  • Acute pain in the chest similar to myocardial infarction with/or without ECG changes
  • Admission to the hospital within 4 hours from onset of the disease.

Exclusion Criteria:

  • Patients with ACS in the preceding 30 days
  • Cerebral blood circulation disorder
  • Recent surgical intervention
  • Extensive burns of degree 2-3
  • Massive wounds and injuries
  • Percutaneous coronary intervention or cardioversion
  • Pregnancy or lactation
  • Malignant tumors of stage 4
  • Severe renal insufficiency (GFR< 30 mL/min)

Sites / Locations

  • Cardiology Research Institute, Tomsk NRMC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FABP group

Arm Description

Coronary angiography and PCI (according to indications).

Outcomes

Primary Outcome Measures

Fatty acid-binding protein (h-FABP) measure
Establishing diagnosis of NSTEMI based on h-FABP test for early detection of myocardial infarction

Secondary Outcome Measures

Troponin I (cTnI) measure
Establishing diagnosis of NSTEMI based on TnI test
Creatine phosphokinase-MB (CPK-MB) measure
Establishing diagnosis of NSTEMI based on CPK-MB test
Creatine phosphokinase (CPK) measure
Establishing diagnosis of NSTEMI based on CPK test

Full Information

First Posted
May 22, 2017
Last Updated
March 6, 2019
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03507270
Brief Title
One-hour Diagnostic Algorithm for NSTEMI
Official Title
One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
After enrollment in the study, patients will undergo the following procedures: 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. Registration of 12-lead electrocardiogram (ECG) (at baseline, after 24 hours, and at the day of discharge). 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. Echocardiography will be performed 24 hours after admission (LVEDV, LVESV, and EF). At day 3, standard echocardiography will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non ST Segment Elevation Myocardial Infarction
Keywords
FABP, non ST Segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FABP group
Arm Type
Other
Arm Description
Coronary angiography and PCI (according to indications).
Intervention Type
Diagnostic Test
Intervention Name(s)
FABP
Intervention Description
Assessment of changes in FABP concentrations
Primary Outcome Measure Information:
Title
Fatty acid-binding protein (h-FABP) measure
Description
Establishing diagnosis of NSTEMI based on h-FABP test for early detection of myocardial infarction
Time Frame
At 4 hours after suspected NSTEMI onset
Secondary Outcome Measure Information:
Title
Troponin I (cTnI) measure
Description
Establishing diagnosis of NSTEMI based on TnI test
Time Frame
At 4 hours after suspected NSTEMI onset
Title
Creatine phosphokinase-MB (CPK-MB) measure
Description
Establishing diagnosis of NSTEMI based on CPK-MB test
Time Frame
At 4 hours after suspected NSTEMI onset
Title
Creatine phosphokinase (CPK) measure
Description
Establishing diagnosis of NSTEMI based on CPK test
Time Frame
At 4 hours after suspected NSTEMI onset

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-80 years old Male patients Acute pain in the chest similar to myocardial infarction with/or without ECG changes Admission to the hospital within 4 hours from onset of the disease. Exclusion Criteria: Patients with ACS in the preceding 30 days Cerebral blood circulation disorder Recent surgical intervention Extensive burns of degree 2-3 Massive wounds and injuries Percutaneous coronary intervention or cardioversion Pregnancy or lactation Malignant tumors of stage 4 Severe renal insufficiency (GFR< 30 mL/min)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyacheslav V. Ryabov, MD, PhD
Organizational Affiliation
Cardiology Research Institute, Tomsk NRMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Research Institute, Tomsk NRMC
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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One-hour Diagnostic Algorithm for NSTEMI

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