Trial · NCT07898345
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Major Adverse Clinical Event | From baseline (t0) through day 365 | Time from baseline (t0) to the first of: all-cause death, nonfatal myocardial infarction, ischemic stroke, or unplanned cardiovascular rehospitalization. Nonfatal myocardial infarction is a new myocardial infarction after and distinct from the index event (after index unstable angina, including a first-ever myocardial infarction). Participants without an event are censored at the last date through which the absence of events was confirmed from verified sources, and no later than day 365. |
| Secondary | All-Cause Mortality | From baseline (t0) through day 365 | 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. |
| Secondary | Cardiovascular Mortality | From baseline (t0) through day 365 | Death due to a documented cardiovascular cause; a subcategory of all-cause death, not an additional component of the primary composite. Deaths of unknown cause are not classified as cardiovascular and are reported separately. |
| Secondary | Nonfatal Myocardial Infarction | From baseline (t0) through day 365 | A new nonfatal myocardial infarction after and distinct from the index acute coronary syndrome event (after index unstable angina, including a first-ever myocardial infarction), confirmed by medical documentation; reinfarction (within 28 days of the index event) and recurrent infarction (after 28 days) are recorded separately. Number of participants with an event. |
| Secondary | Ischemic Stroke | From baseline (t0) through day 365 | Acute focal neurological deficit of ischemic origin confirmed by CT or MRI (if imaging is not possible, by a neurologist's conclusion). Number of participants with an event. |
| Secondary | Unplanned Cardiovascular Rehospitalization | From discharge after the index hospitalization through day 365 after t0 | A new unplanned admission after the end of the continuous index hospitalization for acute coronary syndrome, acute or decompensated heart failure, cardiogenic shock, clinically significant arrhythmia or conduction disorder, or urgent repeat revascularization; transfers within one episode, planned (including staged) admissions and day-hospital care are not counted. Number of participants with an event. |
| Secondary | All-Cause Death or Nonfatal Myocardial Infarction | From baseline (t0) through day 365 | Time to the first occurrence of all-cause death or a nonfatal myocardial infarction after the index acute coronary syndrome episode. |
| Secondary | Acute Heart Failure During Index Hospitalization | Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death) | 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. |
| Secondary | Cardiogenic Shock During Index Hospitalization | Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death) | 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. |
| Secondary | Life-Threatening Arrhythmia During Index Hospitalization | Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death) | 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. |
| Secondary | Repeat Coronary Revascularization | During the index hospitalization and through day 365 after t0 | Occurrence of repeat coronary revascularization documented during the index hospitalization or follow-up. In-hospital and post-discharge events, and planned and urgent revascularizations, will be summarized separately. |
| Secondary | Transfer to Intensive Care Unit | Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death) | 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. |
| Secondary | Length of Index Hospital Stay | From the date of hospital admission to the date of discharge or in-hospital death, whichever came first, assessed up to 365 days | Duration of the index hospitalization, measured in days from hospital admission to discharge or in-hospital death. |
| Secondary | In-Hospital Composite Adverse Clinical Outcome | Up to 365 days (duration of the index hospitalization, from hospital admission to discharge or in-hospital death) | 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. |
| Secondary | Clinically Significant Bleeding (BARC Type 2 or Higher) | During the index hospitalization and through day 365 after t0 | 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, alongside the mean baseline ACTION bleeding risk score by burden level. |
| Secondary | Vital and Functional Status at One-Year Assessment | Vital status through day 365 after t0; functional assessment on days 366-395 after t0 | 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. |
| Secondary | All-Cause Death or Functional Deterioration at One Year | Death through day 365 after t0; functional assessment on days 366-395 after t0 | 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. |
| Other | Composite Adverse Clinical Outcome at 181 Days | From baseline (t0) through day 181 | 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. |
| Other | Prevalence of Malnutrition by GLIM Criteria and Risk of Malnutrition by MNA-SF | Baseline (within 7 days of admission, before discharge) | 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. |
| Other | Serum Albumin and the Primary Composite Outcome | From the research blood sample date through day 365 after t0 | Hazard ratio for the primary composite outcome per 1 standard deviation decrease in serum albumin measured in the research blood sample, from a Cox model adjusted for age and Charlson comorbidity index, with entry at the sample date (delayed entry); albumin is also analyzed jointly with high-sensitivity C-reactive protein. Exploratory analysis in participants with an available result. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07898345/registered