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ST Elevation (STEMI) Myocardial InfarctionNCT07366684

Clinical Characteristics, Frailty, and Prognostic Predictors in Patients Aged 75 and Older With Acute Coronary Syndrome

An observational study of ST Elevation (STEMI) Myocardial Infarction and Non ST Elevation Myocardial Infarction (NSTEMI), run by Clinical Center Niš at 1 site in Serbia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). The research includes both a retrospective and a prospective cohort. Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Percutaneous Coronary Intervention (PCI) and Conservative Medical Therapy
Type of treatment
Surgery or procedure
How many people
550 participants
Where
1 siteSerbia
Study dates
13 May 2026to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Hospitalized patients aged 75 years and older with acute coronary syndrome (STEMI, NSTEMI, unstable angina) treated at the University Clinical Center Niš. Approximately 350 retrospective and 200 prospective patients are expected to be included.

Who may be able to join

  • Age ≥ 75 years
  • Diagnosis of acute coronary syndrome (STEMI, NSTEMI, or unstable angina)
  • Hospitalization in a tertiary care center (University Clinical Center Niš)
  • For prospective cohort: signed informed consent

Who cannot join

  • Refusal to provide informed consent (prospective cohort)
  • Missing or incomplete medical documentation (retrospective cohort)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Svetlana Apostolović contact

+381631094144

drapostolovic@gmail.com

Serbia1 site, 1 recruiting
  • Clinical Center Niš

    Niš, 18000

    Svetlana Apostolović, MD, PhD, +381631094144, drapostolovic@gmail.com

    Recruiting

Other trials in Serbia

About this study

Official title: Investigation of Clinical Characteristics, Frailty, and Predictors of In-Hospital and Six-Month Prognosis in Hospitalized Patients Aged 75 Years and Older With Acute Coronary Syndrome

This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). The research includes both a retrospective and a prospective cohort. The aim is to determine whether frailty scores, combined with clinical and laboratory parameters available at admission, can improve risk prediction for complications and mortality compared with standard risk scores (TIMI, GRACE, Syntax). The study will also compare outcomes between patients treated with percutaneous coronary intervention (PCI) and those treated conservatively with medications. Patients will be followed during hospitalization and for six months after discharge. The results are expected to contribute to more personalized treatment strategies for elderly patients with ACS.

Read the detailed description

This observational study will evaluate clinical characteristics,frailty, and prognostic predictors in patients aged 75 years and older hospitalized with acute coronary syndrome (ACS). The study is designed with two complementary components:

Retrospective cohort (≈350 patients):

Data will be collected from electronic medical records of patients previously hospitalized with ACS. Variables include demographics, comorbidities, laboratory findings (hematology, biochemistry, cardiac biomarkers), ECG changes, echocardiographic parameters, and coronary angiography results. Standard risk scores (TIMI, GRACE, Syntax) will be compared with observed outcomes. Data integrity will be ensured through double-entry verification, and missing values will be addressed using multiple imputation.

Prospective cohort (≈800 patients):

Patients will be consecutively enrolled at admission with ACS. Data collection will include the same parameters as in the retrospective cohort, with additional dynamic laboratory monitoring and frailty assesment. Frailty will be assessed within 48 hours of admission using the Rockwood Frailty Scale, performed by trained investigators. Echocardiography and coronary angiography will be conducted according to institutional protocols. Patients will be followed during hospitalization and 6 months after discharge, using structured case report forms and telephone interviews. Outcomes will include major adverse cardiovascular events (MACE), all-cause mortality, rehospitalizations, PCI-related complications (vascular, gastrointestinal bleeding, neurological), and treatment adherence.

Data management and statistical analysis:

All data will be entered into a secure, password-protected database with regular quality control checks. Statistical analyses will be performed using SPSS v.27 and R. Methods include descriptive statistics, univariate and multivariate logistic regression, ROC curve analysis, and comparison of AUC values. Predictors identified in the retrospective cohort will be validated in the prospective cohort.

The study team consists of cardiologists, statisticians, and trained research staff responsible for patient enrollment, frailty assessment, and data monitoring. Complications and adverse events will be defined according to standardized cardiology guidelines and adjudicated by an independent committee.

The study is conducted in accordance with the Declaration of Helsinki. Retrospective data collection does not require informed consent, while prospective participants will provide written informed consent. The expected contribution is improved risk stratification and more personalized therapeutic approaches for elderly patients with ACS.

Being tested
Percutaneous Coronary Intervention (PCI), Conservative Medical Therapy
Keywords
Acute Coronary Syndrome (ACS), Elderly, Frailty, Percutaneous Coronary Intervention (PCI), Conservative Treatment, Major adverse cardiovascular events (MACE), Prognostic Predictors / Risk Stratification
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Acute Coronary Syndrome, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary Intervention (PCI)Procedure or surgery

    Patients receiving PCI as part of routine clinical care

  • Conservative Medical TherapyOther

    Patients treated conservatively with guideline-directed medical therapy as part of routine care

Study groups in NCT07366684
Study groupRoleWhat they receive
Hospitalized Patients ≥75 Years With Acute Coronary SyndromePatients aged 75 years and older admitted with acute coronary syndrome (STEMI, NSTEMI, or unstable angina). Data will be collected retrospectively and prospectively, including clinical, laboratory, echocardiographic, angiographic, and frailty parameters. Outcomes will be assessed during hospitalization and at 6 months after discharge.
Receives: Procedure: Percutaneous Coronary Intervention (PCI); Other: Conservative Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of treatment strategy (PCI vs conservative therapy) on on all-cause mortality and major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) in elderly patients with acute coronary syndrome (ACS)

    To compare outcomes of patients aged ≥75 years with ACS (STEMI, NSTEMI, unstable angina) treated with percutaneous coronary intervention (PCI) versus conservative medical therapy. The primary outcome includes all-cause mortality and major adverse cardiovascular events (MACE). Unit of Measure: % of patients experiencing event.

    Measured: Peri-procedurally (within 48 hours of PCI or index admission for conservative therapy), at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).

Secondary outcomes (28)
  1. Impact of treatment strategy (PCI vs conservative therapy) on hemorrhagic complications

    Incidence of major bleeding, defined as clinically overt bleeding resulting in hemodynamic compromise, intracranial hemorrhage, bleeding requiring transfusion, or bleeding requiring surgical or endovascular hemostatic intervention; includes gastrointestinal and access-site bleeding. Unit of Measure: Incidence (%)

    Measured: Peri-procedurally (within 48 hours of PCI or index admission) and at discharge (assessed up to 14 days after admission (Day 1)).

  2. Number of Participants with ≥1 All-cause Rehospitalization

    Proportion of patients with ≥1 rehospitalization for any cause and total number of rehospitalizations per patient during follow-up; comparison between PCI and conservative therapy. Unit of Measure: % of patients with ≥1 rehospitalization; count per patient.

    Measured: 6 months after discharge (± 14 days).

  3. Demographic predictors of conservative management

    Patient age and sex as predictors of the decision to pursue conservative medical therapy instead of percutaneous coronary intervention (PCI). Independent predictors will be identified using multivariable logistic regression and reported as odds ratios with 95% confidence intervals.

    Measure: Age (years); Sex (male/female).

    Measured: Baseline (Day 1).

  4. Admission hemoglobin as predictor of conservative management

    Hemoglobin concentration measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: g/L.

    Measured: Baseline.

  5. Admission eGFR (CKD-EPI) as predictor of conservative management

    Estimated glomerular filtration rate (CKD-EPI) measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: mL/min/1.73 m².

    Measured: Baseline.

  6. Admission hs-Troponin I as predictor of conservative management

    High-sensitivity troponin I measured at admission; assay name and 99th percentile documented. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: ng/L.

    Measured: Baseline.

  7. Admission CRP as predictor of conservative management

    C-reactive protein measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: mg/L.

    Measured: Baseline.

  8. Admission BNP/NT-proBNP as predictor of conservative management

    BNP or NT-proBNP measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: pg/mL.

    Measured: Baseline.

  9. Admission HbA1c as predictor of conservative management

    Glycated hemoglobin (HbA1c) measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: %.

    Measured: Baseline.

  10. Composite admission laboratory abnormality score as predictor of conservative management

    Composite score derived from admission laboratory parameters not otherwise specified as individual outcomes. Included analytes: WBC with differential, RBC, HCT, MCV, MCH, MCHC, PLT, Glucose, urea, creatinine, total proteins, albumin, Total cholesterol, HDL, LDL, triglycerides, Na, K, Cl, Ca, AST, ALT, GGT, LDH, CK-MB, TSH.

    Each analyte will be coded as 1 if outside the central hospital laboratory reference range and 0 if within range (assay name, manufacturer, units, and reference intervals documented). The composite score equals the total number of abnormal parameters per patient and will be entered as a single predictor variable in multivariable logistic regression to evaluate its association with the decision for conservative therapy versus PCI. Missing data will be handled by multiple imputation; sensitivity analyses will assess robustness. Unit of Measure: Count (number of abnormal parameters per patient).

    Measured: Baseline.

  11. ECG ischemic changes at admission as predictor of conservative management

    Binary composite coded as 1 if any of the following are present on the admission ECG: ST elevation, ST depression, T-wave inversion, or pathologic q/Q/qS complexes; coded as 0 if none are present. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Unit of measure: Presence/absence (yes/no).

    Measured: Baseline

  12. ECG rhythm and arrhythmias at admission as predictor of conservative management

    Binary composite coded as 1 if any of the following are present on the admission ECG: atrial fibrillation (any), atrial flutter, supraventricular tachycardia, premature atrial complexes, premature ventricular complexes, non-sustained VT, sustained VT, ventricular fibrillation, or accelerated idioventricular rhythm; coded as 0 if none are present. Evaluated as a predictor of the decision for conservative therapy versus PCI. Unit of measure: Presence/absence (yes/no).

    Measured: Baseline.

  13. ECG conduction abnormalities at admission as predictor of conservative management

    Binary composite coded as 1 if any of the following are present on the admission ECG: sinoatrial block, sick sinus syndrome, atrioventricular block (any degree), right bundle branch block, left bundle branch block, left anterior hemiblock, or left posterior hemiblock; coded as 0 if none are present. Evaluated as a predictor of the decision for conservative therapy versus PCI.

    Measured: Baseline

  14. Angiographic high-risk anatomy composite as predictor of conservative management

    Binary composite coded as 1 if any of the following are present on coronary angiography prior to the treatment decision: left main coronary lesion (≥50% luminal stenosis), multivessel coronary disease (≥2 epicardial vessels with significant stenosis), bifurcation lesion, or ≥70% stenosis in any vessel; coded as 0 if none are present. Evaluated as a predictor of the decision to pursue conservative medical therapy versus PCI in multivariable logistic regression. Unit of measure: Presence/absence (yes/no).

    Measured: Peri-procedurally (immediately after angiography); values used are those available at or prior to the documented treatment decision (decision documented within 48 hours of admission).

  15. Left Ventricular Ejection Fraction as predictor of conservative management

    Categorical coded as 1 if LVEF ≤40%, coded as 2 if 41-49%, coded as 3 if ≥50%, based on Teichholz, Simpson biplane, or visual estimation if biplane unavailable. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.

    Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.

  16. E/e' ratio as predictor of conservative management

    Binary composite coded as 1 if average E/e' ≥16, coded as 0 if <16. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.

    Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.

  17. Pericardial effusion as predictor of conservative management

    Binary coded as 1 if effusion present, coded as 0 if absent. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.

    Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.

  18. Left Atrial Volume Index as predictor of conservative management

    Categorical coded as 1 if LAVI ≥34 mL/m², coded as 0 if <34 mL/m². Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.

    Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.

  19. Wall Motion Score Index as predictor of conservative management

    Categorical coded as 1 if WMSI >1.0, coded as 0 if ≤1.0. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.

    Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.

  20. Valvular regurgitation as predictor of conservative management

    Binary composite coded as 1 if any of the following are present: aortic regurgitation, mitral regurgitation, pulmonary regurgitation, or tricuspid regurgitation; coded as 0 if none are present. Evaluated as a predictor of conservative therapy versus PCI in multivariable logistic regression. Examinations will be performed using the GE Healthcare Vivid 6 ultrasound system (General Electric) in our central echocardiography laboratory, following standardized protocols.

    Measured: At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.

  21. Comorbidity predictors of conservative management

    Presence of predefined comorbid conditions recorded at admission and used as predictors of the decision for conservative therapy versus PCI. Each comorbidity will be recorded using standard clinical definitions and ICD codes where available. Comorbidities will be coded as binary variables (yes/no); chronic kidney disease will be classified by KDIGO stage (CKD stage 1-5). Candidate comorbid predictors will be evaluated in univariate analyses and included in multivariable logistic regression based on clinical relevance and univariate p<0.10. Missing data will be handled by multiple imputation; sensitivity analyses will be performed.

    Measured: At admission (baseline, pre-intervention/decision).

  22. Frailty predictors of conservative management

    Frailty assessed at admission using the Rockwood Clinical Frailty Scale (CFS) and the Hopkins frailty instrument; assessor initials and assessment timing recorded. Scores modeled primarily as continuous and secondarily as prespecified categorical variables; inclusion in multivariable logistic regression guided by univariate screening and clinical relevance; missing data handled by multiple imputation. Measure: Rockwood CFS coded as: 0 (score 1-3); 1 (score 4-6); 2 (score 7-9). Hopkins frailty coded as: 0 (score 0); 1 (score 1-2); 2 (score 3-5). Raw Rockwood CFS (1-9) and raw Hopkins score (numeric) will be recorded.

    Measured: At admission (baseline, pre-intervention/decision).

  23. Number of Participants with Major Adverse Cardiovascular Events (MACE)

    Composite endpoint defined as cardiovascular death, myocardial infarction, or stroke. Participants will be coded as positive if any of these events occur, and negative if none occur. Unit of measure: Presence/absence (yes/no).

    Measured: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).

  24. Number of Participants with Cardiovascular Rehospitalization

    Presence/absence of rehospitalization due to cardiovascular causes (including acute coronary syndrome, heart failure, arrhythmia, stroke, or repeat revascularization). Unit of measure: Presence/absence (yes/no).

    Measured: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).

  25. Number of Participants with All-cause Mortality

    Presence/absence of death from any cause. Unit of measure: Presence/absence (yes/no).

    Measured: Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).

  26. Correlation between clinical predictors and clinical outcomes (in-hospital MACE and 6-month all-cause mortality)

    The outcomes are in-hospital major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) and all-cause mortality at 6 months. Each outcome will be reported separately. Candidate predictors include demographic characteristics, prespecified comorbidities, admission laboratory values (including renal function and eGFR), echocardiographic measures (e.g., LVEF, LV volumes, LAVI, TAPSE), ECG parameters (e.g., ST elevation/depression, T-wave inversion, rhythm abnormalities, conduction blocks), and angiographic findings (culprit vessel, multivessel disease, left main disease, percent stenosis). Independent predictors will be identified using multivariable logistic regression for in-hospital MACE and Cox proportional hazards models for 6-month mortality. Full variable definitions, units, assay names, and reference ranges are provided in the SAP.

    Measured: Predictors measured at admission (baseline). In-hospital MACE assessed during hospitalization (up to 15 days after admission). Six-month all-cause mortality assessed 6 months after discharge (±14 days).

  27. Correlation between frailty scores and cognitive categories and clinical outcomes (in-hospital MACE and 6-month all-cause mortality).

    Frailty and cognition will be assessed at admission using the Rockwood Clinical Frailty Scale (CFS, range 1-9; higher = greater frailty), the Hopkins frailty instrument (range 0-5; higher = greater frailty), and the Mini-Mental State Examination (MMSE, range 0-30; higher = better cognition). Clinical outcomes are in-hospital MACE (composite of cardiovascular death, myocardial infarction, and stroke) and all-cause mortality at 6 months. Results will be reported by the prespecified score categories (CFS 1-3 / 4-6 / 7-9; Hopkins 0 / 1-2 / 3-5; MMSE <24 vs ≥24) and expressed as the percentage of patients with each outcome within categories. Statistical analysis will include correlation coefficients (Spearman or Pearson as appropriate) and multivariable models comparing categories (logistic regression for in-hospital MACE; Cox proportional hazards for 6-month mortality); reference groups, covariates and all cutoffs are specified in the SAP.

    Measured: Scores measured at admission, outcomes assessed at discharge (up to 14 days after admission), and outcomes reassessed 6 months after discharge (± 14 days).

  28. Secondary complications and adverse events

    Incidence of periprocedural complications, gastrointestinal bleeding, neurological complications, and psychiatric disorders (e.g., psycho-organic syndrome).

    Measured: Peri-procedurally, at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start13 May 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07366684
Sponsor's protocol ID
ACS75-NIS-2025
Status last verified
May 2026
First submitted
1 Dec 2025
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD), including demographics, clinical, laboratory, echocardiographic, angiographic, frailty scores, and outcomes, will be made available. A data dictionary will also be provided. Data will be shared with qualified researchers upon reasonable request, after publication of the main results, for up to 5 years. Access will require approval by the principal investigator and a signed data use agreement.

Publications

  • Narendren A, Whitehead N, Burrell LM, Yudi MB, Yeoh J, Jones N, Weinberg L, Miles LF, Lim HS, Clark DJ, Al-Fiadh A, Farouque O, Koshy AN. Management of Acute Coronary Syndromes in Older People: Comprehensive Review and Multidisciplinary Practice-Based Recommendations. J Clin Med. 2024 Jul 28;13(15):4416. doi: 10.3390/jcm13154416.

    PubMed 39124683
  • Morici N, De Servi S, De Luca L, Crimi G, Montalto C, De Rosa R, De Luca G, Rubboli A, Valgimigli M, Savonitto S. Management of acute coronary syndromes in older adults. Eur Heart J. 2022 Apr 19;43(16):1542-1553. doi: 10.1093/eurheartj/ehab391.

    PubMed 34347065
  • H Ratcovich, P Palm, J Faerch, L Bang, T Engstroem, H H Tilsted, L Holmvang, Prevalence and prognosis of frailty in patients >70 years old with acute coronary syndrome referred to invasive angiography. Eur Heart J Acute Cardiovasc Care. 2023;12(Suppl 1):zuad036.045. doi:10.1093/ehjacc/zuad036.045

  • Szummer K, Montez-Rath ME, Alfredsson J, Erlinge D, Lindahl B, Hofmann R, Ravn-Fischer A, Svensson P, Jernberg T. Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry. Circulation. 2020 Nov 3;142(18):1700-1708. doi: 10.1161/CIRCULATIONAHA.120.050645. Epub 2020 Sep 1.

    PubMed 32867508
  • Aranzulla TC, Radano I, Civera S, Musumeci G. Acute coronary syndrome in elderly and frail patients. European Society of Cardiology - Council for Cardiology Practice, CardioPractice. Published August 6, 2024. Available at: https://www.escardio.org/Councils/Council-for-Cardiology-Practice-%28CCP%29/Cardiopractice/acute-coronary-syndrome-in-elderly-and-frail-patients

  • Damluji AA, Forman DE, Wang TY, Chikwe J, Kunadian V, Rich MW, Young BA, Page RL 2nd, DeVon HA, Alexander KP; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health. Management of Acute Coronary Syndrome in the Older Adult Population: A Scientific Statement From the American Heart Association. Circulation. 2023 Jan 17;147(3):e32-e62. doi: 10.1161/CIR.0000000000001112. Epub 2022 Dec 12.

    PubMed 36503287
  • Rout A, Moumneh MB, Kalra K, Singh S, Garg A, Kunadian V, Biscaglia S, Alkhouli MA, Rymer JA, Batchelor WB, Nanna MG, Damluji AA. Invasive Versus Conservative Strategy in Older Adults >/=75 Years of Age With Non-ST-segment-Elevation Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2024 Nov 5;13(21):e036151. doi: 10.1161/JAHA.124.036151. Epub 2024 Nov 4.

    PubMed 39494560

Questions about this trial

What is this clinical trial studying?

An observational study of ST Elevation (STEMI) Myocardial Infarction and Non ST Elevation Myocardial Infarction (NSTEMI), run by Clinical Center Niš at 1 site in Serbia.

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 2 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: looking for participants now, as of the sponsor's last update on 15 May 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 Serbia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Svetlana Apostolović (+381631094144, drapostolovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of treatment strategy (PCI vs conservative therapy) on on all-cause mortality and major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) in elderly patients with acute coronary syndrome (ACS) (time frame: Peri-procedurally (within 48 hours of PCI or index admission for conservative therapy), at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07366684, which also lists 7 linked publications.

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 15 May 2026.

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