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

NCT04709900 | Recruiting

• 1 other identifier: NNF19OC0057592
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Chest Syndrome; Acute Myocardial Infarction; Heart Failure; Stroke; Cardiovascular Diseases

Keywords

Cardiac CT; Chest pain; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

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

  3 years

Secondary Outcomes (15)

• Individual components of the primary endpoint

  3 years

• Acute myocardial infarction stratified by subtype

  12 months

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

  3 years

• All-cause mortality

  3 years

• All-cause mortality

  10 years

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Diagnostic Test: CT angiography, FFR-CT and stress CT myocardial perfusion

Standard care group

NO INTERVENTION

Evaluation and treatment strategy according to contemporary clinical practice

Interventions

CT angiography, FFR-CT and stress CT myocardial perfusion DIAGNOSTIC_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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure; Stroke; Cardiovascular Diseases; Chest Pain

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Klaus F Kofoed, MD

  Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus F Kofoed, MD

CONTACT

004535458569; Klaus.kofoed@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associated Research Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: December 3, 2021
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Statistical Analysis Plan and study protocol a time of publication
• Access Criteria: Curated by principle investigator according to contemporary law

Locations

DK (1)