CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
NCT ID: NCT04709900
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2021-12-03
2031-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy
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.
Standard care group
Evaluation and treatment strategy according to contemporary clinical practice
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for non-acute coronary evaluation
* Status of coronary revascularization
1. With previous coronary revascularization - all patients
2. Without previous coronary revascularization
1. Ageā„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
* 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
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Klaus Fuglsang Kofoed
Clinical associated Research Professor
Principal Investigators
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Klaus F Kofoed, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark
Locations
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Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Klaus F Kofoed, MD, DmSc
Role: primary
Other Identifiers
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NNF19OC0057592
Identifier Type: -
Identifier Source: org_study_id