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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

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

Intervention / Treatment
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* Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy | Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion<br>* 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.<br>|
| No Intervention: Standard care group<br>Evaluation and treatment strategy according to contemporary clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual components of the primary endpoint | cardiovascular death; acute myocardial infarction; stroke or hospitalization for heart failure | 3 years | 
| Acute myocardial infarction stratified by subtype | Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018 | 12 months | 
| Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment | Cardiovascular hospitalizations | 3 years | 
| All-cause mortality | All-cause mortality | 3 years | 
| All-cause mortality | Long-term registry based all-cause mortality at 10 years | 10 years | 
| Number and type of diagnostic tests performed | 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 | 12 months | 
| Number of invasive coronary test not leading to coronary revascularization | number of invasive procedures | 12 months | 
| Number of coronary revascularization | Coronary bypass surgery and/or percutaneous coronary intervention | 3 years | 
| Cumulative iodinated contrast volume | Cardiac computed tomography, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, invasive optical coherence tomography | 12 months | 
| Cumulative radiation dose | 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 | 12 months | 
| 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 | 12 months | 
| Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization) | Minor procedural complications | 12 months | 
| Patients diagnosed with non-cardiac disease as likely explanation for symptoms | non-cardiac diseases causing chest pain | 12 months | 
| Seattle Angina Questionaire | Seattle Angina Questionaire pre-randomization, 3 months and 12 months after randomization | 3 months and 12 months | 
| Quality of life by EQ-5D-5L instrument | Quality of life estimated by EQ-5D-5L instrument pre-randomization, 3 months and 12 months after randomization | 3 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac CT, Chest pain, Coronary artery disease