Chronic Coronary SyndromePERFORM-CCSNCT05865600
Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome
A study testing Optimization of guideline-directed medical therapy, Immediate referral for invasive coronary angiography and 3-months delayed referral for invasive coronary angiography in people with Chronic Coronary Syndrome and Myocardial Ischemia, run by Gødstrup Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Myocardial Ischemia, Stable Angina
- What is being tested?
- Optimization of guideline-directed medical therapy, Immediate referral for invasive coronary angiography and 3-months delayed referral for invasive coronary angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- Additional inclusion criteria for randomized trial:
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
- Additional exclusion criteria for randomized trial:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Gødstrup Hospital
Herning, Central Jutland, 7400
Morten Böttcher, Prof, 25775134 ext. 0045, morboett@rm.dk
Jacob H Søby, MD, 61659131 ext. 0045, jasoeb@rm.dk
About this study
Official title: Perfusion Estimation for Optimal Revascularization and Medical Therapy in Chronic Coronary Syndrome - a Randomized Trial
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.
Read the detailed description
BACKGROUND:
Ischemic heart disease (IHD) is highly prevalent in Western countries and an emerging disease in developing countries around the globe. While the Danish incidence rate of IHD for both females and males has been declining during the last 15 years, the prevalence has stabilized at 165,000 patients in 2018 due to enhanced survival.
Ischemic heart disease is caused by atherosclerotic plaque formation in the epicardial coronary arteries, abnormalities in the coronary microcirculation, spasms in the vessel wall, or a combination thereof. This may result in chest discomfort or dyspnoea leading to frequent primary care consultations and admissions on the suspicion of acute coronary syndrome. To emphasize the chronic nature of the disease, the European Society of Cardiology has replaced the previous nomenclature of stable coronary artery disease with chronic coronary syndrome (CCS) in their latest guidelines from 2019.
When cardiac imaging is used to diagnose and select treatment in patients with CCS, guidelines recommend non-invasive functional imaging modalities in patients with an intermediate or high clinical likelihood of IHD or in patients with prior revascularization. In patients with prior myocardial infarction or percutaneous coronary intervention, studies have found higher diagnostic accuracy of [15O]H2O cardiac PET/CT with measurement of absolute quantification of myocardial perfusion to diagnose obstructive coronary artery disease compared with single-photon emission computed tomography and magnetic resonance imaging. Current European guidelines recommend myocardial revascularization in addition to guideline-directed medical therapy (GDMT) in CCS patients with large areas of ischemia (≥ 10%) in the left ventricle to improve prognosis.
Since the publication of these guidelines, a large randomized trial of initial invasive versus conservative strategy in patients with moderate-severe ischemia on stress testing has been published with no observed prognostic benefit of an initial invasive strategy in these patients. However, patients assigned to an initial invasive strategy had a greater improvement in angina-related health status as compared with a conservative strategy, with larger differences observed in patients who were more symptomatic at baseline. The study is limited by the high use of stress ECG (25% of participants) which has a very low diagnostic power and the high proportion of asymptomatic participants at baseline (35%).
It is unknown whether the results of MPI with absolute quantification of myocardial perfusion can improve the selection of patients with an additional symptomatic benefit of an initial invasive strategy compared with GDMT.
METHODS:
Patients with symptomatic CCS referred for clinically indicated [15O]H2O cardiac PET/CT will be included in a prospective cohort and assessed with questionnaires at baseline, 3, 6, 12, 60, and 120 months. Clinical outcomes will be assessed through national registries.
Patients with abnormal perfusion and a clinical indication for ICA will undergo coronary CT angiography and a six-minute walking test. Hereafter, they will be randomized 1:1 to immediate referral to ICA or 3 months delayed referral to ICA. Both groups will undergo optimization of GDMT with consultations every two weeks.
At 3 and 6 months, both groups will undergo repeated questionnaires, [15O]H2O cardiac PET/CT and a six-minute walking test.
Enrollment in the cohort study and randomized trial will continue until 200 randomized patients have reached the 3 months assessment.
- Being tested
- Optimization of guideline-directed medical therapy, Immediate referral for invasive coronary angiography, 3-months delayed referral for invasive coronary angiography, Standard of care
- Keywords
- Myocardial Ischemia, Angina Pectoris, Coronary Artery Disease, Coronary Angiography, Computed Tomography Angiography, Myocardial Perfusion Imaging
- Medical subject headings
- Myocardial Ischemia, Angina, Stable, Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of guideline-directed medical therapyOther
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.
Immediate referral for invasive coronary angiographyDiagnostic test
Immediate referral for invasive coronary angiography
3-months delayed referral for invasive coronary angiographyDiagnostic test
3-months delayed referral for invasive coronary angiography
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: Optimization of guideline-directed medical therapy; Diagnostic Test: 3-months delayed referral for invasive coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic relief
Seattle Angina Questionnaire-7 angina frequency score = 100 (0-100 with higher scores indicating less frequent angina)
Measured: After 3 months following a positive [15O]H2O cardiac PET/CT
Secondary outcomes (25)
Walking capacity
Meters walked in six-minute walking test
Measured: 3 and 6 months after randomization
Angina frequency
Seattle Angina Questionnaire-7 angina frequency score (0-100 with higher scores indicating less frequent angina)
Measured: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Physical limitation
Seattle Angina Questionnaire-7 physical limitation score (0-100 with higher scores indicating less physical limitation)
Measured: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Quality of life-score
Seattle Angina Questionnaire-7 quality of life score (0-100 with higher scores indicating better quality of life)
Measured: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Health status
Seattle Angina Questionnaire-7 summary score (0-100 where 0 denotes the lowest reportable health status and 100 the highest)
Measured: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Dyspnea
Rose Dyspnea Scale. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea
Measured: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Work Ischemic Symptom score
Work Ischemic Symptom score summary score. The scoring system is currently under development.
Measured: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Hyperemic myocardial blood flow
Global and territorial hyperemic myocardial blood flow (ml/g/min) of perfusable myocardium on [15O]H2O cardiac PET/CT.
Measured: 3 and 6 months after randomization
Myocardial flow reserve
Global and territorial myocardial flow reserve (unitless measure) on [15O]H2O cardiac PET/CT.
Measured: 3 and 6 months after randomization
Coronary flow capacity
Coronary flow capacity incorporates hyperemic myocardial blood flow and myocardial flow reserve into a 5-point ordinal scale ranging from myocardial steal indicating very poor coronary flow capacity to normal coronary flow capacity. All data is derived from [15O]H2O cardiac PET/CT.
Measured: 3 and 6 months after randomization
Coronary revascularization
Percutaneous coronary intervention and/or coronary artery bypass grafting
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Coronary revascularization
Percutaneous coronary intervention and/or coronary artery bypass grafting
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
Myocardial infarction
All myocardial infarctions
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Myocardial infarction
All myocardial infarctions
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
All-cause mortality
All deaths
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
All-cause mortality
All deaths
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
Cardiovascular mortality
All cardiovascular deaths
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Cardiovascular mortality
All cardiovascular deaths
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
Unstable angina
Unstable angina
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Unstable angina
Unstable angina
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
Unplanned hospitalization
Any hospitalization requiring overnight stay not electively planned
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Unplanned hospitalization
Any hospitalization requiring overnight stay not electively planned
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
De novo heart failure
New diagnosis of heart failure
Measured: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
De novo heart failure
New diagnosis of heart failure
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
Use of CCTA, MPI, and ICA
Use of coronary CT angiography, myocardial perfusion imaging and invasive coronary angiography
Measured: 10 years after randomization or index [15O]H2O cardiac PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start23 May 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten Böttcher, Prof, Principal investigator, University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865600
- Sponsor's protocol ID
- 1-10-72-185-22
- Acronym
- PERFORM-CCS
- Status last verified
- Aug 2025
- First submitted
- 2 May 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be readily available due to Danish legislation. Data can be shared upon reasonable request if a research protocol is submitted to the investigators and approval for data sharing is obtained via Danish authorities.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Estimation for Optimal Revascularization and Medical Therapy in Chronic Coronary Syndrome - a Randomized Trial
- ClinicalTrials.gov ID
- NCT05865600
- Acronym / sponsor ID
- PERFORM-CCS / 1-10-72-185-22
- Keywords
- Myocardial Ischemia, Angina Pectoris, Coronary Artery Disease, Coronary Angiography, Computed Tomography Angiography, Myocardial Perfusion Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Ischemic heart disease (IHD) is highly prevalent in Western countries and an emerging disease in developing countries around the globe. While the Danish incidence rate of IHD for both females and males has been declining during the last 15 years, the prevalence has stabilized at 165,000 patients in 2018 due to enhanced survival.
Ischemic heart disease is caused by atherosclerotic plaque formation in the epicardial coronary arteries, abnormalities in the coronary microcirculation, spasms in the vessel wall, or a combination thereof. This may result in chest discomfort or dyspnoea leading to frequent primary care consultations and admissions on the suspicion of acute coronary syndrome. To emphasize the chronic nature of the disease, the European Society of Cardiology has replaced the previous nomenclature of stable coronary artery disease with chronic coronary syndrome (CCS) in their latest guidelines from 2019.
When cardiac imaging is used to diagnose and select treatment in patients with CCS, guidelines recommend non-invasive functional imaging modalities in patients with an intermediate or high clinical likelihood of IHD or in patients with prior revascularization. In patients with prior myocardial infarction or percutaneous coronary intervention, studies have found higher diagnostic accuracy of [15O]H2O cardiac PET/CT with measurement of absolute quantification of myocardial perfusion to diagnose obstructive coronary artery disease compared with single-photon emission computed tomography and magnetic resonance imaging. Current European guidelines recommend myocardial revascularization in addition to guideline-directed medical therapy (GDMT) in CCS patients with large areas of ischemia (≥ 10%) in the left ventricle to improve prognosis.
Since the publication of these guidelines, a large randomized trial of initial invasive versus conservative strategy in patients with moderate-severe ischemia on stress testing has been published with no observed prognostic benefit of an initial invasive strategy in these patients. However, patients assigned to an initial invasive strategy had a greater improvement in angina-related health status as compared with a conservative strategy, with larger differences observed in patients who were more symptomatic at baseline. The study is limited by the high use of stress ECG (25% of participants) which has a very low diagnostic power and the high proportion of asymptomatic participants at baseline (35%).
It is unknown whether the results of MPI with absolute quantification of myocardial perfusion can improve the selection of patients with an additional symptomatic benefit of an initial invasive strategy compared with GDMT.
METHODS:
Patients with symptomatic CCS referred for clinically indicated [15O]H2O cardiac PET/CT will be included in a prospective cohort and assessed with questionnaires at baseline, 3, 6, 12, 60, and 120 months. Clinical outcomes will be assessed through national registries.
Patients with abnormal perfusion and a clinical indication for ICA will undergo coronary CT angiography and a six-minute walking test. Hereafter, they will be randomized 1:1 to immediate referral to ICA or 3 months delayed referral to ICA. Both groups will undergo optimization of GDMT with consultations every two weeks.
At 3 and 6 months, both groups will undergo repeated questionnaires, [15O]H2O cardiac PET/CT and a six-minute walking test.
Enrollment in the cohort study and randomized trial will continue until 200 randomized patients have reached the 3 months assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cohort study | Other | Other: Standard of careAll 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 |
| Immediate referral to invasive coronary angiography | Experimental | Other: Optimization of guideline-directed medical therapy, Diagnostic Test: Immediate referral for invasive coronary angiographyPatients 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. |
| Delayed referral to invasive coronary angiography | Experimental | Other: Optimization of guideline-directed medical therapy, Diagnostic Test: 3-months delayed referral for invasive coronary angiographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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
Key exclusion criteria (15 listed)
- Ongoing acute coronary syndrome or acute coronary syndrome within 30 days
- Contraindications for adenosine
- Patients not able to breath hold (severe COPD/asthma)
- Pregnant women, including women who are potentially pregnant or lactating
- Allergy to iomeron
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimization of guideline-directed medical therapyConsultation 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. | Other | Delayed referral to invasive coronary angiography, Immediate referral to invasive coronary angiography |
| Immediate referral for invasive coronary angiographyImmediate referral for invasive coronary angiography | Diagnostic test | Immediate referral to invasive coronary angiography |
| 3-months delayed referral for invasive coronary angiography3-months delayed referral for invasive coronary angiography | Diagnostic test | Delayed referral to invasive coronary angiography |
| Standard of careStandard of care | Other | Cohort study |
Primary outcome
Symptomatic relief
Time frame: After 3 months following a positive [15O]H2O cardiac PET/CT
Seattle Angina Questionnaire-7 angina frequency score = 100 (0-100 with higher scores indicating less frequent angina)
25 secondary outcomes
Walking capacity
Time frame: 3 and 6 months after randomization
Angina frequency
Time frame: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Physical limitation
Time frame: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Quality of life-score
Time frame: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Health status
Time frame: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Dyspnea
Time frame: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Work Ischemic Symptom score
Time frame: 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT
Hyperemic myocardial blood flow
Time frame: 3 and 6 months after randomization
Myocardial flow reserve
Time frame: 3 and 6 months after randomization
Coronary flow capacity
Time frame: 3 and 6 months after randomization
Coronary revascularization
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Coronary revascularization
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
Myocardial infarction
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Myocardial infarction
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
All-cause mortality
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
All-cause mortality
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
Cardiovascular mortality
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Cardiovascular mortality
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
Unstable angina
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Unstable angina
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
Unplanned hospitalization
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
Unplanned hospitalization
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
De novo heart failure
Time frame: 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT
De novo heart failure
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
Use of CCTA, MPI, and ICA
Time frame: 10 years after randomization or index [15O]H2O cardiac PET/CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be readily available due to Danish legislation. Data can be shared upon reasonable request if a research protocol is submitted to the investigators and approval for data sharing is obtained via Danish authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morten Böttcher, Prof principal investigator
University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of guideline-directed medical therapy, Immediate referral for invasive coronary angiography and 3-months delayed referral for invasive coronary angiography in people with Chronic Coronary Syndrome and Myocardial Ischemia, run by Gødstrup Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob H Søby, MD (61659131 ext. 0045, jasoeb@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic relief (time frame: After 3 months following a positive [15O]H2O cardiac PET/CT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.