RecruitingNot ApplicableNCT04709900

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

DYnamic CT Stress Myocardial perfusioN, CT Fractional Flow Reserve and Coronary CT Angiography for Optimized treatMent Strategy In Patients With sTable Chest Pain syndromEs


Sponsor

Rigshospitalet, Denmark

Enrollment

2,000 participants

Start Date

Dec 3, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria9

  • 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 Criteria9

  • 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

Interventions

DIAGNOSTIC_TESTCT 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.


Locations(1)

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

Copenhagen, Denmark

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NCT04709900


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