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

Rigshospitalet, Denmark2,000 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Coronary Artery Disease Chest Syndrome

Interventions

CT angiography, FFR-CT and stress CT myocardial perfusionDIAGNOSTIC_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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Major Adverse Cardiovascular Events

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

Time frame: 3 years

Secondary Outcomes

Individual components of the primary endpoint

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

Time frame: 3 years

Acute myocardial infarction stratified by subtype

Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018

Time frame: 12 months

Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment

Cardiovascular hospitalizations

Time frame: 3 years

All-cause mortality

Time frame: 3 years

All-cause mortality

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

Time frame: 10 years

Number and type of diagnostic tests performed

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

Time frame: 12 months

Number of invasive coronary test not leading to coronary revascularization

number of invasive procedures

Time frame: 12 months

Number of coronary revascularization

Coronary bypass surgery and/or percutaneous coronary intervention

Time frame: 3 years

Cumulative iodinated contrast volume

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

Time frame: 12 months

Cumulative radiation dose

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

Time frame: 12 months

Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization)

death, cardiac arrest, cardiac arrhytmia, acute myocardial infarction, stroke, bleeding, unplanned revascularization and any complication requiring and/or prolonging hospitalizaation at least 24 hours

Time frame: 12 months

Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)

Minor procedural complications

Time frame: 12 months

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

non-cardiac diseases causing chest pain

Time frame: 12 months

Seattle Angina Questionaire

Seattle Angina Questionaire pre-randomization, 3 months and 12 months after randomization

Time frame: 3 months and 12 months

Quality of life by EQ-5D-5L instrument

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

Time frame: 3 months and 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts