CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT angiography, FFR-CT and stress CT myocardial perfusion.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction, Heart Failure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DYnamic CT Stress Myocardial perfusioN, CT Fractional Flow Reserve and Coronary CT Angiography for Optimized treatMent Strategy In Patients With sTable Chest Pain syndromEs
Overview
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
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
Interventions
- Diagnostic test 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.
Primary outcome measures
- Major Adverse Cardiovascular Events [Time frame: 3 years]
Secondary outcome measures (12)
- Individual components of the primary endpoint [Time frame: 3 years]
- Acute myocardial infarction stratified by subtype [Time frame: 12 months]
- Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment [Time frame: 3 years]
- All-cause mortality [Time frame: 3 years]
- All-cause mortality [Time frame: 10 years]
- Number and type of diagnostic tests performed [Time frame: 12 months]
- Number of invasive coronary test not leading to coronary revascularization [Time frame: 12 months]
- Number of coronary revascularization [Time frame: 3 years]
- Cumulative iodinated contrast volume [Time frame: 12 months]
- Cumulative radiation dose [Time frame: 12 months]
- Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization) [Time frame: 12 months]
- Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region o — Copenhagen
Identifiers
NCT: NCT04709900 · NNF19OC0057592