Coronary Artery DiseaseDYNAMITENCT04709900
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
A study testing CT angiography, FFR-CT and stress CT myocardial perfusion in people with Coronary Artery Disease and Chest Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction
- What is being tested?
- CT angiography, FFR-CT and stress CT myocardial perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Dec 2021to Dec 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Known renal impairment (estimated Glomerular Filtration Rate below <30 ml/min)
- Known x-ray contrast allergy
- Known intolerance to adenosine infusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
Klaus F Kofoed, MD, DmSc, +45 35458569, Klaus.kofoed@regionh.dk
Jesper J Linde, MD, Ph.D
About this study
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
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.
Read the 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
- Conditions
- Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction, Heart Failure, Stroke, Cardiovascular Diseases
- Being tested
- CT angiography, FFR-CT and stress CT myocardial perfusion
- Keywords
- Cardiac CT, Chest pain, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Stroke, Cardiovascular Diseases, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiography, FFR-CT and stress CT myocardial perfusionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy Receives: Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion |
| Standard care group | No intervention | Evaluation and treatment strategy according to contemporary clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure
Measured: 3 years
Secondary outcomes (15)
Individual components of the primary endpoint
cardiovascular death; acute myocardial infarction; stroke or hospitalization for heart failure
Measured: 3 years
Acute myocardial infarction stratified by subtype
Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018
Measured: 12 months
Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment
Cardiovascular hospitalizations
Measured: 3 years
All-cause mortality
All-cause mortality
Measured: 3 years
All-cause mortality
Long-term registry based all-cause mortality at 10 years
Measured: 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
Measured: 12 months
Number of invasive coronary test not leading to coronary revascularization
number of invasive procedures
Measured: 12 months
Number of coronary revascularization
Coronary bypass surgery and/or percutaneous coronary intervention
Measured: 3 years
Cumulative iodinated contrast volume
Cardiac computed tomography, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, invasive optical coherence tomography
Measured: 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
Measured: 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
Measured: 12 months
Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)
Minor procedural complications
Measured: 12 months
Patients diagnosed with non-cardiac disease as likely explanation for symptoms
non-cardiac diseases causing chest pain
Measured: 12 months
Seattle Angina Questionaire
Seattle Angina Questionaire pre-randomization, 3 months and 12 months after randomization
Measured: 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
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start3 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Klaus F Kofoed, MD, Principal investigator, Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709900
- Sponsor's protocol ID
- NNF19OC0057592
- Acronym
- DYNAMITE
- Status last verified
- Dec 2022
- First submitted
- 12 Jan 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the main results of the trial, anonymized data will be made available to other researchers through the Zenodo open data repository.