Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05865600

Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome

Led by Gødstrup Hospital · Updated on 2025-12-10

570

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

We will establish a cohort of 570 symptomatic chronic coronary syndrome patients undergoing 15O-water PET and assess their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomized to immediate or delayed referral to invasive coronary angiography with concomitant optimization of guideline-directed medical therapy with repeated 15O-water PET and questionnaires at 3 and 6 months. The primary objective is to compare the potential benefit of early invasive coronary angiography (ICA) versus guideline directed medical therapy (GDMT) on symptomatic relief defined as freedom of angina after 3 months following a positive \[15O\]H2O cardiac PET/CT in patients with symptomatic chronic coronary syndrome.

CONDITIONS

Official Title

Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Willing and able to understand, read, and sign informed consent
  • Known ischemic heart disease defined by previous myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or prior coronary imaging showing atherosclerosis
  • Undergoing clinically indicated 15O-water cardiac PET/CT due to chest discomfort or dyspnea as angina equivalent
  • For randomized trial: abnormal perfusion on initial 15O-water cardiac PET/CT with specific blood flow and tissue perfusion defect criteria
  • Clinical indication for invasive coronary angiography determined by a multidisciplinary team
Not Eligible

You will not qualify if you...

  • Ongoing acute coronary syndrome or one within the past 30 days
  • Contraindications to adenosine including severe asthma, advanced heart block without pacemaker, or severe aortic stenosis
  • Inability to hold breath due to severe COPD or asthma
  • Pregnant, potentially pregnant, or lactating women
  • Allergy to iomeron contrast
  • Life expectancy less than 2 years
  • Severe valvular heart disease
  • Reduced kidney function with estimated glomerular filtration rate under 40 ml/min
  • Inability to give consent
  • For randomized trial: unprotected left main coronary artery stenosis or very large perfusion defect indicating severe disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gødstrup Hospital

Herning, Central Jutland, Denmark, 7400

Actively Recruiting

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Research Team

J

Jacob H Søby, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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