Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome

NCT05865600 | Recruiting

• 1 other identifier: 1-10-72-185-22
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Coronary Syndrome; Myocardial Ischemia; Stable Angina; Coronary Artery Disease

Keywords

Myocardial Ischemia; Angina Pectoris; Coronary Artery Disease; Coronary Angiography; Computed Tomography Angiography; Myocardial Perfusion Imaging

Outcome Measures

Primary Outcomes (1)

• Symptomatic relief

  Seattle Angina Questionnaire-7 angina frequency score = 100 (0-100 with higher scores indicating less frequent angina)

  After 3 months following a positive [15O]H2O cardiac PET/CT

Secondary Outcomes (25)

• Walking capacity

  3 and 6 months after randomization

• Angina frequency

  3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT

• Physical limitation

  3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT

• Quality of life-score

  3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT

• Health status

  3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT

Study Arms (3)

Cohort study

OTHER

All patients with symptomatic chronic coronary syndrome undergoing clinically referred \[15O\]H2O cardiac PET/CT will be included in a prospective cohort with repeated symptom questionnaires and outcomes registered in national registries. A total of 570 patients are expected to be included in order to have 200 randomized patients reaching the 3-month assessment

Other: Standard of care

Immediate referral to invasive coronary angiography

EXPERIMENTAL

Patients with abnormal perfusion on \[15O\]H2O cardiac PET/CT and clinical indication for invasive coronary angiography randomized to immediate referral for invasive coronary angiography with concomitant optimization of guideline-directed medical therapy. Enrollment will continue until a total of 200 randomized patients reach the 3-month assessment.

Other: Optimization of guideline-directed medical therapy; Diagnostic Test: Immediate referral for invasive coronary angiography

Delayed referral to invasive coronary angiography

EXPERIMENTAL

Patients with abnormal perfusion on \[15O\]H2O cardiac PET/CT and clinical indication for invasive coronary angiography randomized to 3-months delayed referral for invasive coronary angiography with concomitant optimization of guideline-directed medical therapy. Enrollment will continue until a total of 200 randomized patients reach the 3-month assessment.

Other: Optimization of guideline-directed medical therapy; Diagnostic Test: 3-months delayed referral for invasive coronary angiography

Interventions

Immediate referral for invasive coronary angiography DIAGNOSTIC_TEST

Immediate referral for invasive coronary angiography

Immediate referral to invasive coronary angiography

Optimization of guideline-directed medical therapy OTHER

Consultation every second week with optimization of guideline-directed medical therapy according to 2019 ESC guidelines on chronic coronary syndrome. Focus will be on risk-factor modification and anti-anginal medication with the treatment aim to achieve freedom from angina and dyspnea with a heart rate at rest ≤ 60 beats/min and systolic blood pressure \> 100 mmHg.

Delayed referral to invasive coronary angiography; Immediate referral to invasive coronary angiography

3-months delayed referral for invasive coronary angiography DIAGNOSTIC_TEST

3-months delayed referral for invasive coronary angiography

Delayed referral to invasive coronary angiography

Standard of care OTHER

Standard of care

Cohort study

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
• Known ischemic heart disease defined as one of the following
• Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting
• Previous coronary computed tomography angiography or invasive coronary angiography documenting atherosclerosis.
• Undergoing clinically indicated \[15O\]H2O cardiac PET/CT due to chest discomfort or dyspnea as angina equivalent
• Initial \[15O\]H2O cardiac PET/CT with abnormal perfusion defined as all of the following
• Hyperemic myocardial blood flow (hMBF) ≤2.3 mL/min/g in at least two adjacent myocardial segments
• Relative hMBF ≤ 65% in at least two adjacent segments as compared with the mean hMBF of the two adjacent segments with the highest mean hMBF
• Tissue perfusion defect extent ≥ 5% based on indices of relative hypoperfusion
• Clinical indication for invasive coronary angiography decided at a multidisciplinary conference between consultants in nuclear medicine and cardiology

You may not qualify if:

• Ongoing acute coronary syndrome or acute coronary syndrome within 30 days
• Contraindications for adenosine
• Severe asthma
• Advanced atrioventricular block without pacemaker
• Severe aortic stenosis
• Patients not able to breath hold (severe COPD/asthma)
• Pregnant women, including women who are potentially pregnant or lactating
• Allergy to iomeron
• Life expectancy of less than 2 years
• Severe valvular disease
• Reduced kidney function with an estimated glomerular filtrations rate \<40 ml/min
• Inability to consent
• Unprotected left main coronary artery stenosis on coronary CT angiography
• Very large perfusion defect on initial \[15O\]H2O cardiac PET/CT indicating left main coronary artery stenosis or balanced ischemia defined as tissue perfusion defect extent based on indices of absolute hMBF ≥ 20% in two or more myocardial territories supplied by coronary arteries with an Agatston calcium score ≥ 300

Sponsors & Collaborators

• Gødstrup Hospital: lead

Study Sites (1)

Gødstrup Hospital

Herning, Central Jutland, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Angina, Stable; Coronary Artery Disease; Angina Pectoris

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Morten Böttcher, Prof

  University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob H Søby, MD

CONTACT

61659131; jasoeb@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be blinded to the specific result of the initial \[15O\]H2O cardiac PET/CT. The result will be reported as normal, abnormal, or suspicion of unprotected left main coronary stenosis (exclusion criteria) until the termination of the study. Investigators and invasive coronary angiography operators are not blinded to the specific result of the initial \[15O\]H2O cardiac PET/CT in order to evaluate clinical indication for invasive coronary angiography. The coronary CT angiography will only be evaluated for unprotected left main coronary artery stenosis - the rest of the coronary CT angiography as well as the two additional \[15O\]H2O cardiac PET/CT scans at 3 and 6 months assessment will only be analyzed after the termination of the study. Investigators will be blinded to the results of baseline, 3, and 6 month questionnaires and walking distances until the termination of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All eligible patients are included in a prospective cohort with repeated questionnaires. Patients with abnormal perfusion and clinical indication for invasive coronary angiography are randomized 1:1 in permuted blocks with random varying sizes of 4,6 and 8 to either immediate invasive coronary angiography or delayed invasive coronary angiography via a standard computerized random-number generator stratified for age ≥70 years and sex (REDcap). Proper concealment of randomization is obtained by the use of an external randomization service (Clinical Trial Unit, Dept. of Clinical Medicine, Aarhus University, Denmark).

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 19, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)