What is this study trying to find out about chest pain syndromes?

This study evaluates whether a combined approach using dynamic CT myocardial stress perfusion, CT fractional flow reserve, and coronary CT angiography can improve clinical outcomes and relieve symptoms in patients with stable chest pain. Researchers aim to see if this imaging-guided treatment strategy leads to better health compared to usual care. The trial is sponsored by Rigshospitalet, Denmark.

Who may be eligible for this chest pain clinical trial?

Adults with chest pain suspected or confirmed to be caused by ischemic heart disease may be eligible. Both patients with and without previous coronary revascularization can join, with some age and symptom criteria for those without prior procedures. The trial includes all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this chest pain clinical trial?

Study-related care, including all imaging tests, treatments, and trial visits, is provided at no cost. However, personal travel expenses or other costs related to getting to study visits may vary and might not be covered.

Actively Recruiting

Phase Not Applicable

All Genders

ID04709900

Using Combined Dynamic CT Stress Myocardial Perfusion, Fractional Flow Reserve, and Coronary CT Angiography to Guide Treatment in Patients with Stable Chest Pain Syndromes

Led by Rigshospitalet, Denmark · Updated on 2022-12-12

2000

Participants Needed

Research Sites

365 weeks

Total Duration

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

All Genders

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

Research Team

Klaus F Kofoed, MD

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