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

Rigshospitalet

Status

Enrolling

Conditions

Coronary Artery Disease

Stroke

Chest Syndrome

Cardiovascular Diseases

Heart Failure

Acute Myocardial Infarction

Treatments

Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04709900

NNF19OC0057592

Details and patient eligibility

About

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.

Full 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

Enrollment

2,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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