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

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

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

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

Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction, Heart Failure, Stroke, Cardiovascular Diseases

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.

Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment

Cardiac CT, Exercise ECG, perfusion Positron Emission Tomography, perfusion Single-photon emission computed tomography, perfusion magnetic resonance, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, optical coherence tomography

Cardiac computed tomography, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, invasive optical coherence tomography

Cardiac CT, perfusion Positron Emission Tomography, perfusion Single-photon emission computed tomography, perfusion magnetic resonance, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, optical coherence tomography

Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization)

death, cardiac arrest, cardiac arrhytmia, acute myocardial infarction, stroke, bleeding, unplanned revascularization and any complication requiring and/or prolonging hospitalizaation at least 24 hours

Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)

Quality of life estimated by EQ-5D-5L instrument pre-randomization, 3 months and 12 months after randomization

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 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 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

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

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