NCT04709900RecruitingNot Applicable
DYnamic CT Stress Myocardial perfusioN, CT Fractional Flow Reserve and Coronary CT Angiography for Optimized treatMent Strategy In Patients With sTable Chest Pain syndromEs
Rigshospitalet, Denmark2 sites in 1 country2,000 target enrollmentStarted: December 3, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 2,000
- Locations
- 2
- Primary Endpoint
- Major Adverse Cardiovascular Events
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Major Adverse Cardiovascular Events
Time Frame: 3 years
cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure
Secondary Outcomes
- Number of coronary revascularization(3 years)
- Number of invasive coronary test not leading to coronary revascularization(12 months)
- Quality of life by EQ-5D-5L instrument(3 months and 12 months)
- Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment(3 years)
- Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization)(12 months)
- Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)(12 months)
- Seattle Angina Questionaire(3 months and 12 months)
- Acute myocardial infarction stratified by subtype(12 months)
- All-cause mortality(10 years)
- Number and type of diagnostic tests performed(12 months)
- Individual components of the primary endpoint(3 years)
- Cumulative iodinated contrast volume(12 months)
- Patients diagnosed with non-cardiac disease as likely explanation for symptoms(12 months)
- Cumulative radiation dose(12 months)
Investigators
Klaus Fuglsang Kofoed
Clinical associated Research Professor
Rigshospitalet, Denmark
Study Sites (2)
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