Non ST Segment Elevation Myocardial InfarctionNCT03507270
One-hour Diagnostic Algorithm for NSTEMI
A study testing FABP in people with Non ST Segment Elevation Myocardial Infarction, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Non ST Segment Elevation Myocardial Infarction
- What is being tested?
- FABP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 2 May 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Pregnancy or lactation
- Malignant tumors of stage 4
- Severe renal insufficiency (GFR< 30 mL/min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- FABP
- Keywords
- FABP, non ST Segment Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FABPDiagnostic test
Assessment of changes in FABP concentrations
| Study group | Role | What they receive |
|---|---|---|
| FABP group | Other | Coronary angiography and PCI (according to indications). Receives: Diagnostic Test: FABP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid-binding protein (h-FABP) measure
Establishing diagnosis of NSTEMI based on h-FABP test for early detection of myocardial infarction
Measured: At 4 hours after suspected NSTEMI onset
Secondary outcomes (3)
Troponin I (cTnI) measure
Establishing diagnosis of NSTEMI based on TnI test
Measured: At 4 hours after suspected NSTEMI onset
Creatine phosphokinase-MB (CPK-MB) measure
Establishing diagnosis of NSTEMI based on CPK-MB test
Measured: At 4 hours after suspected NSTEMI onset
Creatine phosphokinase (CPK) measure
Establishing diagnosis of NSTEMI based on CPK test
Measured: At 4 hours after suspected NSTEMI onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start2 May 2017
- Primary completion1 May 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vyacheslav V. Ryabov, MD, PhD, Principal investigator, Cardiology Research Institute, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507270
- Sponsor's protocol ID
- CRI-156
- Status last verified
- Jun 2026
- First submitted
- 22 May 2017
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration
- ClinicalTrials.gov ID
- NCT03507270
- Acronym / sponsor ID
- CRI-156
- Keywords
- FABP, non ST Segment Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center study
| Arm | Type | Receives |
|---|---|---|
| FABP group | Other | Diagnostic Test: FABPCoronary angiography and PCI (according to indications). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FABPAssessment of changes in FABP concentrations | Diagnostic test | FABP group |
Primary outcome
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
3 secondary outcomes
Troponin I (cTnI) measure
Time frame: At 4 hours after suspected NSTEMI onset
Creatine phosphokinase-MB (CPK-MB) measure
Time frame: At 4 hours after suspected NSTEMI onset
Creatine phosphokinase (CPK) measure
Time frame: At 4 hours after suspected NSTEMI onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vyacheslav V. Ryabov, MD, PhD principal investigator
Cardiology Research Institute, Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FABP in people with Non ST Segment Elevation Myocardial Infarction, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acid-binding protein (h-FABP) measure (time frame: At 4 hours after suspected NSTEMI onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.