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One-hour Diagnostic Algorithm for NSTEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507270
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non ST Segment Elevation Myocardial Infarction Diagnostic Test: FABP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-center study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
FABP group
Coronary angiography and PCI (according to indications).
 Diagnostic Test: FABP
Assessment of changes in FABP concentrations


Outcome Measures
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Primary Outcome Measures :
  1. Fatty acid-binding protein (h-FABP) measure [ Time Frame: At 4 hours after suspected NSTEMI onset ]
    Establishing diagnosis of NSTEMI based on h-FABP test for early detection of myocardial infarction


Secondary Outcome Measures :
  1. Troponin I (cTnI) measure [ Time Frame: At 4 hours after suspected NSTEMI onset ]
    Establishing diagnosis of NSTEMI based on TnI test

  2. Creatine phosphokinase-MB (CPK-MB) measure [ Time Frame: At 4 hours after suspected NSTEMI onset ]
    Establishing diagnosis of NSTEMI based on CPK-MB test

  3. Creatine phosphokinase (CPK) measure [ Time Frame: At 4 hours after suspected NSTEMI onset ]
    Establishing diagnosis of NSTEMI based on CPK test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507270


Locations
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Russian Federation
Cardiology Research Institute, Tomsk NRMC
Tomsk, Russian Federation, 634012
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
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Principal Investigator: Vyacheslav V. Ryabov, MD, PhD Cardiology Research Institute, Tomsk NRMC
More Information
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT03507270    
Other Study ID Numbers: FABP
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
FABP
non ST Segment Elevation Myocardial Infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases