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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Heart Failure; Stroke; Cardiovascular Diseases; Acute Myocardial Infarction; Chest Syndrome
• Interventions: Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion

• Registration Number: NCT04709900
• Lead Sponsor: Rigshospitalet, Denmark

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

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-12-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12
• Primary Completion: 2024-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	CT angiography, FFR-CT and stress CT myocardial perfusion	CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	3 years	cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure

Secondary Outcome Measures

Name	Time	Method
Number of coronary revascularization	3 years	Coronary bypass surgery and/or percutaneous coronary intervention
Number of invasive coronary test not leading to coronary revascularization	12 months	number of invasive procedures
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
Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment	3 years	Cardiovascular hospitalizations
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
Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)	12 months	Minor procedural complications
Seattle Angina Questionaire	3 months and 12 months	Seattle Angina Questionaire pre-randomization, 3 months and 12 months after randomization
Acute myocardial infarction stratified by subtype	12 months	Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018
All-cause mortality	10 years	Long-term registry based all-cause mortality at 10 years
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
Cumulative iodinated contrast volume	12 months	Cardiac computed tomography, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, invasive optical coherence tomography
Individual components of the primary endpoint	3 years	cardiovascular death; acute myocardial infarction; stroke or hospitalization for heart failure
Patients diagnosed with non-cardiac disease as likely explanation for symptoms	12 months	non-cardiac diseases causing chest pain
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

Trial Locations

Locations (1)

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen; 🇩🇰 Copenhagen, Denmark