Actively Recruiting
Dynamic CT Stress Myocardial Perfusion, CT Fractional Flow Reserve, and Coronary CT Angiography for Treatment Strategy in Stable Chest Pain Syndromes
Led by Rigshospitalet, Denmark · Updated on 2022-12-12
2000
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining dynamic CT myocardial stress perfusion, CT fractional flow reserve (FFR-CT), and coronary CT angiography can improve health outcomes and symptom relief in patients with stable chest pain syndromes suspected or confirmed to have ischemic heart disease. This randomized, open-label trial compares this combined imaging guided treatment strategy against conventional management in patients with chronic chest pain. The study is conducted in the Capital Region of Copenhagen, Denmark, focusing on reducing major adverse cardiovascular events and improving clinical care. Participants are assigned to one of two groups: one receives treatment guided by the combined dynamic CT stress myocardial perfusion, FFR-CT, and CT coronary angiography results; the other follows standard clinical evaluation and treatment practices. The imaging-based strategy involves a team including a cardiac CT specialist, invasive cardiologist, thoracic surgeon, and cardiology nurse specialist who determine treatment plans such as referral for percutaneous coronary intervention, coronary artery bypass surgery, or optimal medical therapy. Both groups undergo evaluation and treatment as per their assigned strategy. During the study, participants will be monitored over several years with key assessments including major adverse cardiovascular events over 3 years, symptom relief measures like the Seattle Angina Questionnaire at 3 and 12 months, quality of life assessments, hospitalization events, and mortality tracked up to 10 years. Additional data on diagnostic test usage, radiation exposure, procedural complications, and diagnoses explaining symptoms will also be collected. This comprehensive follow-up aims to understand the impact of the imaging-guided strategy on clinical outcomes and patient well-being.
CONDITIONS
Brief Title
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chest pain in patients with clinically suspected or confirmed ischemic heart disease
- Clinical indication for non-acute coronary evaluation
- Patients with previous coronary revascularization
- Patients without previous coronary revascularization aged 65 years or older
- Patients without previous coronary revascularization aged over 50 but under 65 years with typical angina and at least one cardiovascular risk factor or previous myocardial infarction
- Typical angina defined by constrictive chest discomfort, precipitated by physical exertion, and relieved by rest or nitrates within 5 minutes
- Cardiovascular risk factors include hypertension, diabetes, high cholesterol, smoking, family history of ischemic heart disease, previous stroke, or peripheral artery disease
You will not qualify if you...
- Persistent chest pain with signs of ongoing acute myocardial ischemia needing acute coronary intervention
- Hospitalization and discharge with acute coronary syndrome diagnosis (STEMI or NSTEMI) within the past 6 months
- Severe valvular heart disease as primary diagnosis or potential need for valve treatment
- Known severe heart failure with left ventricular ejection fraction less than 35%
- Language, cultural, or mental issues preventing understanding of informed consent
- Known atrial fibrillation
- Known renal impairment with estimated Glomerular Filtration Rate below 30 ml/min
- Known allergy to x-ray contrast
- Known intolerance to adenosine infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo CT angiography, FFR-CT, and dynamic CT stress myocardial perfusion to guide treatment strategies.
1 baseline visit with imaging procedures and additional assessments as needed
Duration - Up to 3 years
Participants receive treatment based on the imaging results, which may include percutaneous coronary intervention, coronary artery bypass surgery, or optimal medical therapy.
Follow-up visits scheduled according to treatment plan
Duration - Up to 10 years
Participants are monitored for clinical outcomes, symptom relief, and quality of life after treatment.
Periodic follow-up visits over several years including assessments at 3 months and 12 months
Trial Site Locations
Total: 1 location
1
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
K
Klaus F Kofoed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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