An observational study in Acute Coronary Syndromes (ACS), sponsored by Samara State Medical University. Not yet recruiting at 2 sites in Russia. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Samara State Medical University · Observational
This study aims to find out whether reduced everyday functioning before the acute illness and malnutrition help predict health outcomes in adults aged 65 years and older hospitalized with acute coronary syndrome (heart attack or unstable angina). About 270 patients (no more than 330) will be enrolled in two hospitals in Samara, Russia.
After their condition has stabilized, and within seven days of admission, researchers will ask patients (or a caregiver) about their everyday functioning before the illness. They will also measure weight, height and calf circumference, ask about recent weight loss and food intake, and use a short questionnaire to screen for risk of malnutrition. With separate consent, two extra tubes of blood (11 mL in total) will be taken during a routine hospital blood draw, without an additional needle stick, so that albumin and C-reactive protein can be measured later. Information about the illness and its treatment will be collected from medical records.
Participants will be followed for one year for death, heart attack, ischemic stroke and unplanned hospitalization for heart or vascular conditions. Their ability to perform everyday activities will be assessed again between days 366 and 395 after enrollment. This is an observational study: participation does not change the medical treatment patients receive.
This is a prospective, two-center observational cohort study of the prognostic value of functional-nutritional status in patients aged 65 years and older hospitalized with acute coronary syndrome (ACS: ST-elevation myocardial infarction, non-ST-elevation myocardial infarction or unstable angina). It is not a randomized or interventional trial; no treatment is assigned by the study. The target enrollment is 270 participants; recruitment continues until 31 December 2027 or until 330 participants are enrolled, whichever comes first.
Baseline (t0) is the date of written informed consent at the first research contact after clinical stabilization, no later than 7 days after admission and before discharge. Baseline assessments are performed at this contact. Patients who die or are discharged before this contact are recorded in the screening log and are not enrolled.
Exposure. The principal exposure is a prespecified functional-nutritional burden: the number of impaired domains (0, 1 or 2), calculated as functional impairment plus GLIM malnutrition.
Supporting constructs. Risk of malnutrition is screened with the Mini Nutritional Assessment - Short Form (MNA-SF score of 11 or less). It is a separate construct, is not part of the burden, and is used in a supporting sensitivity analysis. The standard two-step GLIM procedure (MNA-SF screening followed by the GLIM criteria) is a supporting classification that differs from the research classification; discrepancies are reported. Four phenotypes are described: neither impairment, functional only, nutritional only, and both. The Short Physical Performance Battery is performed when possible before discharge and describes in-hospital physical performance; it is not part of the burden.
Laboratory component. Research blood sampling is part of the protocol and is offered to every participant. With separate consent, two additional serum tubes without additive (5.5 mL each, 11 mL in total) are collected after consent during a routine blood draw, usually on the following day, through the same venipuncture. Serum is stored according to a written laboratory standard operating procedure, and albumin and high-sensitivity C-reactive protein are measured later in batches. The Geriatric Nutritional Risk Index, Controlling Nutritional Status score and Prognostic Nutritional Index are calculated using lymphocyte count and total cholesterol from the first routine tests performed no later than the research sample. Laboratory analyses start at the sampling date (delayed entry), are exploratory, and do not redefine the baseline exposure. Declining the blood sample does not prevent participation.
Outcomes and analysis.
1,493 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's planned enrollment of 270 is below the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Samara State Medical University is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Patients aged 65 years and older hospitalized with acute coronary syndrome at two participating cardiology centers in Samara, Russia. Consecutive patients meeting the eligibility criteria will be screened during hospitalization. Eligible patients who provide written informed consent will undergo baseline functional and nutritional assessment after clinical stabilization, within seven days of admission and before discharge. Participants will be enrolled regardless of their baseline functional or nutritional status.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with cognitive impairment may be included if they retain the ability to understand the study information, provide informed consent, and respond to assessment questions; information about pre-event functional status may be supplemented by a caregiver.
A single prospective cohort of patients aged 65 years and older hospitalized with acute coronary syndrome. After clinical stabilization, functional status before the acute event (Age Is Not a Barrier questionnaire, Clinical Frailty Scale), malnutrition by the GLIM criteria and risk of malnutrition by MNA-SF are assessed. Participants are classified by the predefined functional-nutritional burden (0, 1 or 2 impaired domains) and phenotype, and are followed for clinical and functional outcomes. No treatment is assigned by the investigators.
Other: Functional-Nutritional Burden
Observed prognostic exposure, not an assigned intervention. Functional-nutritional burden is the number of impaired domains: (1) probable pre-frailty or frailty before the acute event (Age Is Not a Barrier score of 3 or more, or Clinical Frailty Scale score of 4 or more); (2) malnutrition according to the GLIM criteria assessed in all participants at inclusion. Unknown domain status is not treated as absent. Risk of malnutrition by MNA-SF (11 points or less) is recorded separately; research blood samples (albumin, high-sensitivity C-reactive protein) are analyzed in exploratory analyses.
Time to First Major Adverse Clinical Event
Time from baseline (t0) to the first occurrence of any of the following: all-cause death, nonfatal myocardial infarction, ischemic stroke, or unplanned cardiovascular rehospitalization. Nonfatal myocardial infarction is defined as a new myocardial infarction occurring after and distinct from the index acute coronary syndrome event; in patients whose index event was unstable angina, this includes a first-ever myocardial infarction. The date of the first qualifying event will be used. Participants without an event will be censored at their last confirmed contact or at day 365, whichever is earlier.
Time frame: From baseline (t0) through day 365
All-Cause Mortality
Death from any cause. The date of death will be established from available medical or other authorized records; the number of deaths and time to death will be assessed.
Time frame: From baseline (t0) through day 365
Cardiovascular Mortality
Death classified as due to a cardiovascular cause based on available supporting clinical documentation. Deaths with unknown cause will not be automatically classified as cardiovascular.
Time frame: From baseline (t0) through day 365
Nonfatal Myocardial Infarction
Occurrence of a new nonfatal myocardial infarction after and distinct from the index acute coronary syndrome event (in patients with index unstable angina, including a first-ever myocardial infarction), confirmed using medical documentation. The number of participants with an event and the time to the first event will be assessed.
Time frame: From baseline (t0) through day 365
Ischemic Stroke
Occurrence of a documented ischemic stroke. The number of participants with an event and the time to the first event will be assessed.
Time frame: From baseline (t0) through day 365
Unplanned Cardiovascular Rehospitalization
Unplanned repeat hospitalization for a cardiovascular condition, established from hospital records or discharge documentation. The number of participants with an event and the time to the first qualifying rehospitalization will be assessed.
Time frame: From discharge after the index hospitalization through day 365 after t0
All-Cause Death or Nonfatal Myocardial Infarction
Time to the first occurrence of all-cause death or a nonfatal myocardial infarction after the index acute coronary syndrome episode.
Time frame: From baseline (t0) through day 365
Acute Heart Failure During Index Hospitalization
Occurrence of acute heart failure documented during the index admission for acute coronary syndrome; number and proportion of participants affected. Events are recorded from medical documentation for the whole index admission; events occurring after baseline (t0) are reported separately.
Time frame: Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death)
Cardiogenic Shock During Index Hospitalization
Occurrence of cardiogenic shock documented during the index admission; number and proportion of participants affected. Events are recorded from medical documentation for the whole index admission; events occurring after baseline (t0) are reported separately.
Time frame: Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death)
Life-Threatening Arrhythmia During Index Hospitalization
Occurrence of a documented life-threatening arrhythmia during the index admission, including ventricular tachycardia or ventricular fibrillation; number and proportion of participants affected. Events are recorded from medical documentation for the whole index admission; events occurring after baseline (t0) are reported separately.
Time frame: Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death)
Repeat Coronary Revascularization
Occurrence of repeat coronary revascularization documented during the index hospitalization or follow-up. In-hospital and post-discharge events will be summarized separately.
Time frame: During the index hospitalization and through day 365 after t0
Transfer to Intensive Care Unit
Number and proportion of participants transferred to an intensive care unit during the index hospitalization. Events are recorded from medical documentation for the whole index admission; events occurring after baseline (t0) are reported separately.
Time frame: Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death)
Length of Index Hospital Stay
Duration of the index hospitalization, measured in days from hospital admission to discharge or in-hospital death.
Time frame: From the date of hospital admission to the date of discharge or in-hospital death, whichever came first, assessed up to 365 days
In-Hospital Composite Adverse Clinical Outcome
Occurrence of at least one of the following during the index hospitalization: death, cardiogenic shock, acute heart failure, ventricular tachycardia or ventricular fibrillation, or Bleeding Academic Research Consortium (BARC) type 3 or higher bleeding. Events are recorded from medical documentation for the whole index admission; events occurring after baseline (t0) are reported separately.
Time frame: Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death)
Clinically Significant Bleeding (BARC Type 2 or Higher)
Occurrence of bleeding classified as Bleeding Academic Research Consortium (BARC) type 2 or higher. Events during the index hospitalization and during subsequent follow-up will be described.
Time frame: During the index hospitalization and through day 365 after t0
Vital and Functional Status at One-Year Assessment
Participants will be classified as (1) alive without functional deterioration, (2) alive with functional deterioration, or (3) deceased within 365 days after t0. Deterioration is a reduction in at least one of four Barthel Index items (bathing, dressing, bed-to-chair transfer, or mobility) relative to pre-acute-coronary-syndrome functioning. Functional status not established at follow-up, including death after day 365 but before assessment, will be reported separately as unknown.
Time frame: Vital status through day 365 after t0; functional assessment on days 366-395 after t0
All-Cause Death or Functional Deterioration at One Year
Death from any cause within 365 days after t0, or functional deterioration at the follow-up assessment on days 366-395, defined as a reduction in at least one of four Barthel Index items (bathing, dressing, bed-to-chair transfer, mobility) compared with functioning before the acute coronary syndrome. Participants whose functional status is unknown are not classified and are reported separately.
Time frame: Death through day 365 after t0; functional assessment on days 366-395 after t0
Composite Adverse Clinical Outcome at 181 Days
Time to the first occurrence of all-cause death, recurrent nonfatal myocardial infarction, ischemic stroke, or unplanned cardiovascular rehospitalization through the end of day 181 after t0, by event date; the planned interim contact takes place on days 182-211. Prespecified exploratory outcome, described without formal hypothesis testing.
Time frame: From baseline (t0) through day 181
Prevalence of Malnutrition by GLIM Criteria and Risk of Malnutrition by MNA-SF
Proportion of participants with malnutrition according to the GLIM criteria (research classification in all participants; severity) and with risk of malnutrition according to MNA-SF (11 points or less), with 95% confidence intervals; agreement between MNA-SF and GLIM (2 x 2 table, proportion of agreement, direction of discordance) and between the research classification and the standard two-step GLIM procedure; proportion of participants in whom each GLIM criterion could be assessed.
Time frame: Baseline (within 7 days of admission, before discharge)
Serum Albumin, High-Sensitivity C-Reactive Protein and Laboratory Nutritional Indices and the Primary Composite Outcome
Association of serum albumin and high-sensitivity C-reactive protein (separately and jointly) and of the Geriatric Nutritional Risk Index, Controlling Nutritional Status score and Prognostic Nutritional Index with the primary composite outcome after the research blood sample date (delayed entry), including adjustment for high-sensitivity C-reactive protein; exploratory analysis in participants with an available sample.
Time frame: From the research blood sample date through day 365 after t0
Plan to share: No — There is currently no plan to share individual participant-level data with external researchers. Study findings will be disseminated through scientific publications in aggregate form.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2029, 27 months later.
Of 237 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 27 months is below that.
Counting every sponsor, half of 274 studies reached it within 35 months; a quarter within 18 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Samara State Medical University