Clinical trial NCT04709900: CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Chest Syndrome
Acute Myocardial Infarction
Heart Failure
Stroke
Cardiovascular Diseases
Keywords: Cardiac CT
Chest pain
Coronary artery disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

     1. Age≥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:

* 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

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 3 years
Secondary outcomes:
measure: Individual components of the primary endpoint
timeFrame: 3 years
measure: Acute myocardial infarction stratified by subtype
timeFrame: 12 months
measure: Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment
timeFrame: 3 years
measure: All-cause mortality
timeFrame: 3 years
measure: All-cause mortality
timeFrame: 10 years
measure: Number and type of diagnostic tests performed
timeFrame: 12 months
measure: Number of invasive coronary test not leading to coronary revascularization
timeFrame: 12 months
measure: Number of coronary revascularization
timeFrame: 3 years
measure: Cumulative iodinated contrast volume
timeFrame: 12 months
measure: Cumulative radiation dose
timeFrame: 12 months
measure: Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization)
timeFrame: 12 months
measure: Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)
timeFrame: 12 months
measure: Patients diagnosed with non-cardiac disease as likely explanation for symptoms
timeFrame: 12 months
measure: Seattle Angina Questionaire
timeFrame: 3 months and 12 months
measure: Quality of life by EQ-5D-5L instrument
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Study officials:
affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark
name: Klaus F Kofoed, MD
role: PRINCIPAL_INVESTIGATOR
References: