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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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
Show all 9Show fewer
  • 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
Show all 9Show fewer
  • 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.

Klaus F Kofoed, MD contact

004535458569

Klaus.kofoed@regionh.dk

Denmark1 site, 1 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

    Recruiting

Other trials in Denmark

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
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 groups in NCT04709900
Study groupRoleWhat they receive
Intervention groupActive comparatorCT 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 groupNo interventionEvaluation 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.

  1. Major Adverse Cardiovascular Events

    cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure

    Measured: 3 years

Secondary outcomes (15)

  1. Individual components of the primary endpoint

    cardiovascular death; acute myocardial infarction; stroke or hospitalization for heart failure

    Measured: 3 years

  2. Acute myocardial infarction stratified by subtype

    Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018

    Measured: 12 months

  3. 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

  4. All-cause mortality

    All-cause mortality

    Measured: 3 years

  5. All-cause mortality

    Long-term registry based all-cause mortality at 10 years

    Measured: 10 years

  6. 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

  7. Number of invasive coronary test not leading to coronary revascularization

    number of invasive procedures

    Measured: 12 months

  8. Number of coronary revascularization

    Coronary bypass surgery and/or percutaneous coronary intervention

    Measured: 3 years

  9. Cumulative iodinated contrast volume

    Cardiac computed tomography, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, invasive optical coherence tomography

    Measured: 12 months

  10. 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

  11. 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

  12. Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)

    Minor procedural complications

    Measured: 12 months

  13. Patients diagnosed with non-cardiac disease as likely explanation for symptoms

    non-cardiac diseases causing chest pain

    Measured: 12 months

  14. Seattle Angina Questionaire

    Seattle Angina Questionaire pre-randomization, 3 months and 12 months after randomization

    Measured: 3 months and 12 months

  15. 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.

  1. First posted14 Jan 2021
  2. Study start3 Dec 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04709900
Sponsor's protocol ID
NNF19OC0057592
Acronym
DYNAMITE
Status last verified
Nov 2026
First submitted
12 Jan 2021
Last updated
5 Nov 2026
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Klaus F Kofoed, MD (004535458569, Klaus.kofoed@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiovascular Events (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04709900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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