CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes

Официальное название

DYnamic CT Stress Myocardial perfusioN, CT Fractional Flow Reserve and Coronary CT Angiography for Optimized treatMent Strategy In Patients With sTable Chest Pain syndromEs

Обзор

The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.

Подробное описание

Trial design

The DYNAMITE trial is an investigator-initiated, randomised controlled, open-labelled trial conducted in the Capital Region of Copenhagen, Denmark

The following hypothesis will be tested:

* First primary hypothesis: A treatment strategy guided by combined dynamic CT myocardial stress perfusion, FFR-CT and CT coronary angiography improves clinical outcome compared with a conventional management strategy in patients with chronic chest pain syndromes * Second primary hypothesis: A treatment strategy guided by combined dynamic CT stress myocardial perfusion, FFR-CT and CT coronary angiography results in improved symptom relief compared with a conventional management strategy in patients with chronic chest pain syndromes

Вмешательства

• Диагностический тест CT angiography, FFR-CT and stress CT myocardial perfusion
  The study intervention team consists of a specialist in Cardiac CT imaging, an invasive cardiologist, a thoracic surgeon and a cardiology nurse specialist. Treatment strategy defined by the study team based on CT findings involve referral for percutaneous coronary intervention, Coronary Artery Bypass surgery and/or initiation of optimal medical therapy, in addition to potential supplementary diagnostic procedures.

Первичные конечные точки

• Major Adverse Cardiovascular Events [Срок оценки: 3 years]

Вторичные конечные точки (12)

• Individual components of the primary endpoint [Срок оценки: 3 years]
• Acute myocardial infarction stratified by subtype [Срок оценки: 12 months]
• Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment [Срок оценки: 3 years]
• All-cause mortality [Срок оценки: 3 years]
• All-cause mortality [Срок оценки: 10 years]
• Number and type of diagnostic tests performed [Срок оценки: 12 months]
• Number of invasive coronary test not leading to coronary revascularization [Срок оценки: 12 months]
• Number of coronary revascularization [Срок оценки: 3 years]
• Cumulative iodinated contrast volume [Срок оценки: 12 months]
• Cumulative radiation dose [Срок оценки: 12 months]
• Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization) [Срок оценки: 12 months]
• Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Chest pain in patients with clinically suspected or confirmed ischemic heart disease
• Clinical indication for non-acute coronary evaluation
• Status of coronary revascularization

• With previous coronary revascularization - all patients
• Without previous coronary revascularization

• Age≥65 years - all patients with chest pain
• Age>50 - <65 years - typical angina pectoris and at least one cardiovascular risk factor and/or previous myocardial infarction

• Typical angina requiring all 3 criteria present: a) constrictive discomfort in the front of the chest or in the neck, jaw, shoulder or arm, b) precipitated by physical exertion c) relieved by rest or nitrates within 5 min.
• Cardiovascular risk factors: hypertension, diabetes, hypercholesterolemia, current smoking, family history of ischemic heart disease, previous stroke, peripheral artery disease

Критерии исключения

• Persistent chest pain and signs of ongoing acute myocardial ischemia requiring acute coronary intervention
• Hospitalization and discharge with the confirmed diagnosis acute coronary syndrome (STEMI or NSTEMI) within the last 6 months
• Severe valvular heart disease as primary diagnosis and/or in potential need of percutaneous or surgical valve treatment
• Known severe heart failure (LVEF less than 35%)
• Language, cultural or mental factors preventing the patient from understanding the informed consent form
• Known atrial fibrillation
• Known renal impairment (estimated Glomerular Filtration Rate below <30 ml/min)
• Known x-ray contrast allergy
• Known intolerance to adenosine infusion

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

Лечение

Центры проведения

Дания · 1 центр

• Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region o — Copenhagen

Идентификаторы

NCT: NCT04709900 · NNF19OC0057592

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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