DYNAMITE: CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04709900
Collaborator
(none)
2,000
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion
N/A

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
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2031

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Intervention group

CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy

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.

No Intervention: Standard care group

Evaluation and treatment strategy according to contemporary clinical practice

Outcome Measures

Primary Outcome Measures

  1. Major Adverse Cardiovascular Events [3 years]

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

Secondary Outcome Measures

  1. Individual components of the primary endpoint [3 years]

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

  2. Acute myocardial infarction stratified by subtype [12 months]

    Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018

  3. Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment [3 years]

    Cardiovascular hospitalizations

  4. All-cause mortality [3 years]

    All-cause mortality

  5. All-cause mortality [10 years]

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

  6. Number and type of diagnostic tests performed [12 months]

    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

  7. Number of invasive coronary test not leading to coronary revascularization [12 months]

    number of invasive procedures

  8. Number of coronary revascularization [3 years]

    Coronary bypass surgery and/or percutaneous coronary intervention

  9. Cumulative iodinated contrast volume [12 months]

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

  10. Cumulative radiation dose [12 months]

    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

  11. Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization) [12 months]

    death, cardiac arrest, cardiac arrhytmia, acute myocardial infarction, stroke, bleeding, unplanned revascularization and any complication requiring and/or prolonging hospitalizaation at least 24 hours

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

    Minor procedural complications

  13. Patients diagnosed with non-cardiac disease as likely explanation for symptoms [12 months]

    non-cardiac diseases causing chest pain

  14. Seattle Angina Questionaire [3 months and 12 months]

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

  15. Quality of life by EQ-5D-5L instrument [3 months and 12 months]

    Quality of life estimated by EQ-5D-5L instrument pre-randomization, 3 months and 12 months after randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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

  1. With previous coronary revascularization - All patients

  2. Without previous coronary revascularization - Age≥65 years

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of CopenhagenCopenhagenDenmark2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Klaus F Kofoed, MD, Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Klaus Fuglsang Kofoed, Clinical associated Research Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04709900
Other Study ID Numbers:
  • NNF19OC0057592
First Posted:
Jan 14, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Klaus Fuglsang Kofoed, Clinical associated Research Professor, Rigshospitalet, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021