Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease

Обзор

The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD) after a coronary arteriography has been performed. The software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. Thus, the algorithm does not "show the physician specifically what to do", but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.

Подробное описание

To investigate the clinical usefulness of the developed clinical decision support system - the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm will;

* Improve patient prognosis and, * Minimize the risk of re-hospitalization,

compared to patients who are treated without the attending/treating physician knowing the algorithm's prognosis?

Вмешательства

• Другое PM HeartIHD prediction
  The calculated prediction and the explainability factors will be made available to the physician, which the physician then can decide to take into his/hers evaluation about further treatment.

Первичные конечные точки

• Number and duration of readmissions within one month after randomization [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Number and cause of death (all-cause mortality) within one year after randomization [Срок оценки: From randomization to the study and up to 1 year hereafter]

Вторичные конечные точки (12)

• Readmission(s) within 30 days of the randomization [Срок оценки: Up to 30 days after randomization to the study.]
• Cardiovascular readmission(s) within 30 days of the randomization [Срок оценки: Up to 30 days after randomization to the study.]
• Readmission(s) with acute coronary syndrome [Срок оценки: From randomization to the study and up to 1 year hereafter]
• One-year survival [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Total number of days the primary hospitalization lasts [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Total number of days at the hospital incl. hospitalizations during the first year after inclusion [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Number of hospitalizations the first year [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Number and type of performed cardiac investigations [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Number of cardiac follow-up consultations at the hospital [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Number of check-ups for cardiovascular reasons at the general practitioner [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Number of cardiovascular drugs at discharge [Срок оценки: From randomization to the study and up to 1 year hereafter]
• Dosages (DDD) of drugs at discharge [Срок оценки: Up to 1 year after randomization to study.]

Критерии участия

Критерии включения

• Hospitalized patients in one of the involved departments of cardiology (see below) with;
• Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission

Критерии исключения

• <18 years of age
• Living outside Denmark

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Дания · 1 центр

• Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital. — Copenhagen Ø

Идентификаторы

NCT: NCT06033014 · p-2023-14244

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗