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.

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

Inclusion Criteria:

• Chest pain in patients with clinically suspected or confirmed ischemic heart disease

• Clinical indication for non-acute coronary evaluation

• Status of coronary revascularization

  1. With previous coronary revascularization - all patients

  2. Without previous coronary revascularization

     1. Age≥65 years - all patients with chest pain

     2. 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

Exclusion Criteria:

• 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

Following publication of the main results of the trial, anonymized data will be made available to other researchers through the Zenodo open data repository.

Statistical Analysis Plan and study protocol a time of publication

Curated by principle investigator according to contemporary law