One-hour Diagnostic Algorithm for NSTEMI

NCT03507270 | Completed

• 1 other identifier: FABP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non ST Segment Elevation Myocardial Infarction

Keywords

FABP; non ST Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Troponin I (cTnI) measure

  At 4 hours after suspected NSTEMI onset

• Creatine phosphokinase-MB (CPK-MB) measure

  At 4 hours after suspected NSTEMI onset

• Creatine phosphokinase (CPK) measure

  At 4 hours after suspected NSTEMI onset

Study Arms (1)

FABP group

OTHER

Coronary angiography and PCI (according to indications).

Diagnostic Test: FABP

Interventions

FABP DIAGNOSTIC_TEST

Assessment of changes in FABP concentrations

FABP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute, Tomsk NRMC

Tomsk, 634012, Russia

Location

Study Officials

• Vyacheslav V. Ryabov, MD, PhD

  Cardiology Research Institute, Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center study

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: April 25, 2018
• Study Start: May 2, 2017
• Primary Completion: May 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 7, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)