One-hour Diagnostic Algorithm for NSTEMI

Non ST Segment Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507270
• Other study ID #: FABP
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: May 2018
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non ST Segment Elevation Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Intervention

Diagnostic Test:
• FABP
Assessment of changes in FABP concentrations

Locations

Country	Name	City	State
Russian Federation	Cardiology Research Institute, Tomsk NRMC	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Troponin I (cTnI) measure	Establishing diagnosis of NSTEMI based on TnI test	At 4 hours after suspected NSTEMI onset
Secondary	Creatine phosphokinase-MB (CPK-MB) measure	Establishing diagnosis of NSTEMI based on CPK-MB test	At 4 hours after suspected NSTEMI onset
Secondary	Creatine phosphokinase (CPK) measure	Establishing diagnosis of NSTEMI based on CPK test	At 4 hours after suspected NSTEMI onset