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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Heart Failure; Stroke; Acute Myocardial Infarction; Chest Syndrome
• Intervention / Treatment: Diagnostic test: CT angiography, FFR-CT and stress CT myocardial perfusion

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus F Kofoed, MD; Phone Number: 004535458569; Email: Klaus.kofoed@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
    • Contact: Klaus F Kofoed, MD, DmSc; Phone Number: +45 35458569; Email: Klaus.kofoed@regionh.dk
    • Sub-Investigator: Jesper J Linde, MD, Ph.D
    • Sub-Investigator: Lars V Køber, MD,DmSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy	Diagnostic test: CT 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.
No Intervention: Standard care group; Evaluation and treatment strategy according to contemporary clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events	cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Klaus F Kofoed, MD, Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2031

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Chest pain; Cardiac CT
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Syndrome; Chest Pain
• Other Study ID Numbers: NNF19OC0057592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Following publication of the main results of the trial, anonymized data will be made available to other researchers through the Zenodo open data repository.
• IPD Sharing Time Frame: Statistical Analysis Plan and study protocol a time of publication
• IPD Sharing Access Criteria: Curated by principle investigator according to contemporary law
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No