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

Primary Purpose

Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CT angiography, FFR-CT and stress CT myocardial perfusion
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Cardiac CT, Chest pain, Coronary artery disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 - Age≥65 years

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Standard care group

Arm Description

CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy

Evaluation and treatment strategy according to contemporary clinical practice

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular Events
cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2021
Last Updated
December 8, 2022
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04709900
Brief Title
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction, Heart Failure, Stroke, Cardiovascular Diseases
Keywords
Cardiac CT, Chest pain, Coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
CT angiography, FFR-CT and dynamic CT stress myocardial perfusion guided treatment strategy
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
Evaluation and treatment strategy according to contemporary clinical practice
Intervention Type
Diagnostic Test
Intervention Name(s)
CT angiography, FFR-CT and stress CT myocardial perfusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
cardiovascular death, acute myocardial infarction, stroke or hospitalization for heart failure
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Individual components of the primary endpoint
Description
cardiovascular death; acute myocardial infarction; stroke or hospitalization for heart failure
Time Frame
3 years
Title
Acute myocardial infarction stratified by subtype
Description
Subtypes of acute myocardial infarction according to Fourth Universal Definition 2018
Time Frame
12 months
Title
Hospitalization due to unstable angina pectoris, bleeding, pacemaker and/or implantable/cardioverter defibrillator implantation, surgical or percutaneous heart valve treatment
Description
Cardiovascular hospitalizations
Time Frame
3 years
Title
All-cause mortality
Description
All-cause mortality
Time Frame
3 years
Title
All-cause mortality
Description
Long-term registry based all-cause mortality at 10 years
Time Frame
10 years
Title
Number and type of diagnostic tests performed
Description
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
Title
Number of invasive coronary test not leading to coronary revascularization
Description
number of invasive procedures
Time Frame
12 months
Title
Number of coronary revascularization
Description
Coronary bypass surgery and/or percutaneous coronary intervention
Time Frame
3 years
Title
Cumulative iodinated contrast volume
Description
Cardiac computed tomography, invasive coronary angiography, invasive fractional flow reserve, intravascular ultrasound, invasive optical coherence tomography
Time Frame
12 months
Title
Cumulative radiation dose
Description
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
Title
Major procedural complications occuring during procedures (invasive, non-invasive or coronary revascularization)
Description
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
Title
Minor procedural complication specific to type of procedure (invasive, non-invasive or during coronary revascularization)
Description
Minor procedural complications
Time Frame
12 months
Title
Patients diagnosed with non-cardiac disease as likely explanation for symptoms
Description
non-cardiac diseases causing chest pain
Time Frame
12 months
Title
Seattle Angina Questionaire
Description
Seattle Angina Questionaire pre-randomization, 3 months and 12 months after randomization
Time Frame
3 months and 12 months
Title
Quality of life by EQ-5D-5L instrument
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus F Kofoed, MD
Phone
004535458569
Email
Klaus.kofoed@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus F Kofoed, MD
Organizational Affiliation
Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus F Kofoed, MD, DmSc
Phone
+45 35458569
Email
Klaus.kofoed@regionh.dk
First Name & Middle Initial & Last Name & Degree
Jesper J Linde, MD, Ph.D
First Name & Middle Initial & Last Name & Degree
Lars V Køber, MD,DmSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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