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NCT Number: NCT04709900

CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography 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.

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Key information

Conditions

Coronary Artery Disease Acute Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chest Pain Chest Syndrome Coronary Disease Heart Diseases Heart Failure Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Jesper J Linde, MD, Ph.D

SUB_INVESTIGATOR

Klaus F Kofoed, MD, DmSc

CONTACT

[email protected]

+45 35458569

Lars V Køber, MD,DmSc

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT angiography, FFR-CT and stress CT myocardial perfusion

Diagnostic 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.

Primary outcomes

  1. Major Adverse Cardiovascular Events

    Time frame: 3 years

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

Secondary outcomes

  1. Individual components of the primary endpoint

    Time frame: 3 years

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

  2. Acute myocardial infarction stratified by subtype

    Time frame: 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

    Time frame: 3 years

    Cardiovascular hospitalizations

  4. All-cause mortality

    Time frame: 3 years

    All-cause mortality

  5. All-cause mortality

    Time frame: 10 years

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

  6. Number and type of diagnostic tests performed

    Time frame: 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

    Time frame: 12 months

    number of invasive procedures

  8. Number of coronary revascularization

    Time frame: 3 years

    Coronary bypass surgery and/or percutaneous coronary intervention

  9. Cumulative iodinated contrast volume

    Time frame: 12 months

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

  10. Cumulative radiation dose

    Time frame: 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)

    Time frame: 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)

    Time frame: 12 months

    Minor procedural complications

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

    Time frame: 12 months

    non-cardiac diseases causing chest pain

  14. Seattle Angina Questionaire

    Time frame: 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

    Time frame: 3 months and 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Klaus F Kofoed, MD

CONTACT

[email protected]

004535458569

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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

Acronym: DYNAMITE

Important dates

Study start
2021
Primary completion
2024
Study completion
2031
First posted
Jan 14, 2021
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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