One-hour Diagnostic Algorithm for NSTEMI

One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration

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.

Study Overview

• Status: Completed
• Conditions: Non ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Diagnostic test: FABP

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634012
    • Cardiology Research Institute, Tomsk NRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FABP group; Coronary angiography and PCI (according to indications).	Diagnostic test: FABP; Assessment of changes in FABP concentrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatty acid-binding protein (h-FABP) measure	Establishing diagnosis of NSTEMI based on h-FABP test for early detection of myocardial infarction	At 4 hours after suspected NSTEMI onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Troponin I (cTnI) measure	Establishing diagnosis of NSTEMI based on TnI test	At 4 hours after suspected NSTEMI onset
Creatine phosphokinase-MB (CPK-MB) measure	Establishing diagnosis of NSTEMI based on CPK-MB test	At 4 hours after suspected NSTEMI onset
Creatine phosphokinase (CPK) measure	Establishing diagnosis of NSTEMI based on CPK test	At 4 hours after suspected NSTEMI onset

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Vyacheslav V. Ryabov, MD, PhD, Cardiology Research Institute, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: FABP; non ST Segment Elevation Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: FABP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No