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

Stroke Clinical Trial

— DYNAMITE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709900
• Other study ID #: NNF19OC0057592
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: December 2031

Study information

• Verified date: December 2022
• Source: Rigshospitalet, Denmark
• Contact: Klaus F Kofoed, MD
• Phone: 004535458569
• Email: Klaus.kofoed[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2031
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiovascular Diseases
• Chest Pain
• Chest Syndrome
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Stroke
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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