Using advanced cardiac imaging to improve treatment for patients with chest pain
DYnamic CT Stress Myocardial perfusioN, CT Fractional Flow Reserve and Coronary CT Angiography for Optimized treatMent Strategy In Patients With sTable Chest Pain syndromEs
This study is testing if using advanced heart imaging techniques can help people with chest pain get better treatment and feel healthier compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT04709900 on ClinicalTrials.gov |
What this trial studies
The DYNAMITE trial aims to evaluate whether a treatment strategy based on combined dynamic CT myocardial stress perfusion, fractional flow reserve CT (FFR-CT), and coronary CT angiography can enhance clinical outcomes for patients experiencing chronic chest pain syndromes. This randomized controlled trial will compare the effectiveness of this imaging-guided approach against conventional management strategies in improving morbidity and mortality. The study will include patients with suspected or confirmed ischemic heart disease and will assess both clinical outcomes and symptom relief.
Who should consider this trial
Good fit: Ideal candidates include patients aged 50 and older with chronic chest pain and risk factors for ischemic heart disease, or those aged 65 and older with chest pain.
Not a fit: Patients experiencing persistent chest pain with signs of ongoing acute myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of chest pain and reduced risk of serious cardiac events for patients.
How similar studies have performed: Previous studies have shown promise in using advanced imaging techniques for cardiac evaluation, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
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
Where this trial is running
Copenhagen
- Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Klaus F Kofoed, MD — Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark
- Study coordinator: Klaus F Kofoed, MD
- Email: Klaus.kofoed@regionh.dk
- Phone: 004535458569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.