A Phase 3 interventional study of Oxygen-15 Water in Coronary Artery Disease, Microvascular Coronary Artery Disease and Microvascular Coronary Dysfunction, sponsored by Vastra Gotaland Region. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Vastra Gotaland Region · Phase 3, Interventional, and Diagnostic
Among 92 studies in Coronary Artery Disease with a site in Sweden — 14 open to participants now, 24 under way, 3 of them phase 3. Coronary Artery Disease · Sweden.
Among the 92 studies in Coronary Artery Disease with a site in Sweden, this one has the largest planned enrollment of the 71 interventional ones that give a count, is one of 2 that started in 2026, is one of 12 in phase 3, reaches primary completion later than 22 of the 23 other live ones, and was the 92nd registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →14 of the 92 studies in Coronary Artery Disease with a site in Sweden are open now. Recruiting first, the newest first:
Uppsala University · Sites in Sweden
Ages 50–80
Region Skane · Sites in Sweden
Ages 40+ · Healthy volunteers
CSL Behring · Sites in Sweden, United States, Argentina and 32 more countries
Ages 18+
Region Östergötland · Sites in Sweden
Ages 18+
Weill Medical College of Cornell University · Sites in Sweden, United States, Australia and 23 more countries
Ages 18+ · Women only
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
92 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 12 · Phase 3 13 · Phase 4 5
First in 1992; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40,000 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Median enrollment 500 across the 71 interventional studies, 1,356 across the 21 observational. Of the 62 that completed or were terminated, 22 (35%) have results posted.
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45 of 92 have an industry lead sponsor. The 10 most frequent:
Vastra Gotaland Region is the lead sponsor of 276 studies on the registry; 110 are open to participants now.
Vastra Gotaland Region has 4 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Coronary Artery Disease with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06578234Region SkaneHyperemic mYocardial Perfusion by adEnosine at diffeRent Doses | 2026-12-31 |
| NCT07884136Ribocure Pharmaceuticals ABRBD1119 in Coronary Artery Disease (CAD) | 2027-09-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 92 studies in Coronary Artery Disease with a site in Sweden, from their registry updates:
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This study evaluates the prognostic value of quantitative myocardial perfusion imaging using oxygen-15 water positron emission tomography in patients with clinically suspected or known coronary artery disease (main basket), and explores temporal changes in myocardial perfusion related to disease progression, underlying pathophysiological processes, or treatment-related effects (additional baskets).
This open-label, national, multicentre phase III clinical trial employs a core basket-protocol design comprising one main basket cohort and ten additional basket cohorts. The main basket (up to 40 000 participants) evaluates the prognostic value of quantitative myocardial perfusion imaging using oxygen-15 water positron emission tomography (PET) in patients with clinically suspected or known coronary artery disease (one PET examination per participant). Prognostic performance will be assessed for both global and regional perfusion parameters, including rest and stress myocardial blood flow and myocardial flow reserve, in the overall study population and in pre-specified subgroups. The additional baskets aim to explore temporal changes in myocardial perfusion in coronary artery disease and related conditions (two PET examinations per participant), whether driven by disease progression, underlying pathophysiological processes, or treatment-related effects: A) Antianginal treatment basket cohort (n = 40 - 60, pre- vs. on-treatment, follow-up after 2 - 3 months); B) Heart failure treatment basket cohort (n = 40 - 60, pre- vs. on-treatment, follow-up after 2 - 3 months); C) Transcatheter aortic valve implantation basket cohort (n = 40 - 80, pre- vs. post-implantation, follow-up after 3 +/- 2 months); D) Chronic total occlusion basket cohort (n = 60 - 90, pre- vs. on-treatment/post-intervention, follow-up after 3 - 6 months); E) Anti-inflammatory treatment basket cohort (n = 40 - 60, pre- vs. on-treatment, follow-up after 6 +/- 2 months); F) Chronic kidney disease basket cohort (n = 40 - 60, baseline vs. follow-up after 12 +/- 2 months); G) Long-term dialysis basket cohort (n = 40 - 60, baseline vs. follow-up after 12 +/- 2 months); H) Kidney transplantation basket cohort (n = 40 - 60, pre- vs. post-transplantation, follow-up after 12 +/- 2 months); I) Takotsubo syndrome basket cohort (n = 15 - 20, acute phase vs. post-recovery, follow-up after full recovery); J) ST-elevation myocardial infarction basket cohort (n = 40 - 80, baseline (after recent revascularization) vs. follow-up after 6 +/- 2 months). In all baskets, blood samples will be collected when feasible and stored in a biobank for future research.
Inclusion Criteria: 1) Signed written consent (all baskets); 2) Female and male subjects ≥ 18 years (all baskets); 3) Clinically suspected or known coronary artery disease (all baskets); 4) Clinical indication for myocardial perfusion imaging in alignment with current evidence-based practice, clinical guidelines, and/or local routines (most baskets). In case of the additional basket cohorts, subjects must meet one of the following additional criteria: A) Antianginal treatment basket cohort: High pretest probability of coronary artery disease, angina pectoris as the primary symptom, no or recently initiated or inadequate antianginal treatment that can be withheld for a duration equivalent to 3 - 5 drug half-lives, and no prior history of coronary intervention; B) Heart failure treatment basket cohort: Newly diagnosed idiopathic dilated cardiomyopathy and no or recently initiated heart failure therapy; C) Transcatheter aortic valve implantation (TAVI) basket cohort: Severe aortic stenosis accepted for TAVI; D) Chronic total occlusion (CTO) basket cohort: Coronary CTO eligible for i) optimized medical treatment alone, ii) percutaneous coronary intervention, or iii) reducer stent implantation; E) Anti-inflammatory treatment basket cohort: Cardiac sarcoidosis with an indication for anti-inflammatory treatment; F) Chronic kidney disease (CKD) basket cohort: CKD of varying severity, defined as estimated \< 60 ml/min/1.73 m2, not receiving maintenance dialysis at baseline; G) Long-term dialysis basket cohort: Maintenance dialysis in end-stage CKD; H) Kidney transplantation basket cohort: End-stage CKD under evaluation for kidney transplantation; I) Takotsubo syndrome basket cohort: Classic, hemodynamically stable acute Takotsubo syndrome; J) ST-elevation myocardial infarction (STEMI) basket cohort: Recently revascularized acute STEMI. Exclusion Criteria (All Baskets): 1) for the used pharmacological stress agents; 2) Contraindications for PET/CT or PET/MR, such as severe claustrophobia or non-MR-conditional implants; 3) Inability to understand and adhere to all study-related procedures, including participant preparation; 4) Pregnancy or lactation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the main basket, participants will undergo a single quantitative myocardial perfusion imaging examination using oxygen-15 water PET at rest and during pharmacological stress (adenosine or regadenoson). In the additional baskets, the same examination will be performed twice, at baseline and at follow-up. In all baskets, blood samples will be collected when feasible and stored in a biobank for future research.
Drug: Oxygen-15 Water
Oxygen-15 water enables absolute quantification of myocardial blood flow at rest and during pharmacological stress using PET. In the main basket, participants will undergo a single quantitative myocardial perfusion imaging examination using oxygen-15 water PET at rest and during pharmacological stress (adenosine or regadenoson). In the additional baskets, the same examination will be performed twice, at baseline and at follow-up. In all baskets, blood samples will be collected when feasible and stored in a biobank for future research.
Also known as: Oxygen-15-labelled water, [¹⁵O]H₂O, H₂[¹⁵O], ¹⁵O-water, [¹⁵O]water
Prognostic Thresholds of Stress Myocardial Blood Flow for Predicting MACE-1 (Main Basket)
Stress myocardial blood flow thresholds (global and regional, ml/min/g), measured by oxygen-15 water PET during adenosine or regadenoson stress, that best predict time to first occurrence of major adverse cardiovascular events-1 (MACE; defined as a composite of all-cause death and non-fatal myocardial infarction) in participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Prognostic Thresholds of Rest Myocardial Blood Flow for Predicting MACE-1 (Main Basket)
Rest myocardial blood flow thresholds (global and regional, ml/min/g), measured by oxygen-15 water PET at rest, that best predict time to first occurrence of MACE-1 (defined as a composite of all-cause death and non-fatal myocardial infarction) in participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Prognostic Thresholds of Myocardial Flow Reserve for Predicting MACE-1 (Main Basket)
Myocardial flow reserve thresholds (global and regional; ratio of stress to rest myocardial blood flow), measured by oxygen-15 water PET at rest and during adenosine or regadenoson stress, that best predict time to first occurrence of MACE-1 (defined as a composite of all-cause death and non-fatal myocardial infarction) in participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Subgroup-Specific Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting MACE-1 (Main Basket)
Rest and stress myocardial blood flow (MBF; global and regional, ml/min/g) and myocardial flow reserve (global and regional, ratio of stress to rest MBF) thresholds, measured by oxygen-15 water PET at rest and during adenosine or regadenoson stress, that best predict time to first occurrence of MACE-1 (defined as a composite of all-cause death and non-fatal myocardial infarction) in pre-specified subgroups (e.g., age, sex, cardiovascular risk factors, prior revascularization, and prior myocardial infarction) of participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting MACE-2 (Main Basket)
Rest and stress myocardial blood flow (MBF; global and regional, ml/min/g) and myocardial flow reserve (global and regional, ratio of stress to rest MBF) thresholds, measured by oxygen-15 water PET at rest and during adenosine or regadenoson stress, that best predict time to first occurrence of MACE-2 (defined as a composite of cardiovascular death and non-fatal myocardial infarction) in participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Subgroup-Specific Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting MACE-2 (Main Basket)
Rest and stress myocardial blood flow (MBF; global and regional, ml/min/g) and myocardial flow reserve (global and regional, ratio of stress to rest MBF) thresholds, measured by oxygen-15 water PET at rest and during adenosine or regadenoson stress, that best predict time to first occurrence of MACE-2 (defined as a composite of cardiovascular death and non-fatal myocardial infarction) in pre-specified subgroups (e.g., age, sex, cardiovascular risk factors, prior revascularization, and prior myocardial infarction) of participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting Individual Cardiovascular and Non-Cardiovascular Events (Main Basket)
Rest and stress myocardial blood flow (MBF; global and regional, ml/min/g) and myocardial flow reserve (global and regional, ratio of stress to rest MBF) thresholds, measured by oxygen-15 water PET at rest and during adenosine or regadenoson stress, that best predict time to first occurrence of individual events, including all-cause death, cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, and unplanned ischemia-driven coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting, excluding the first 90 days after the PET examination) in participants with clinically suspected or known coronary artery disease (main basket).
Time frame: 2 and 5 years after the PET examination
Change in Myocardial Blood Flow and Myocardial Flow Reserve Over Time (Additional Baskets)
Change from baseline to follow-up in rest and stress myocardial blood flow (MBF; global and regional, ml/min/g) and myocardial flow reserve (global and regional, ratio of stress to rest MBF), measured by oxygen-15 water PET at rest and during adenosine or regadenoson stress. Changes will be assessed in relation to disease progression, underlying pathophysiology, or treatment effects (additional baskets).
Time frame: Baseline and follow-up (2 - 14 months after the baseline PET examination, depending on basket)
Novel and Established Cardiovascular Biomarkers in Relation to Myocardial Perfusion (All Baskets)
Identification and characterization of novel diagnostic and prognostic cardiovascular biomarkers, and re-evaluation of established biomarkers, in biobanked blood samples, using perfusion metrics and other parameters as reference across all basket cohorts.
Time frame: Up to 15 years after the last PET scan
SAEs and SUSARs Within 24 Hours of Oxygen-15 Water Administration (All Baskets)
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) occurring within 24 hours of administration of the investigational medicinal product (oxygen-15 water), across all basket cohorts.
Time frame: Within 24 hours after oxygen-15 water administration
Plan to share: No — There are currently no plans to make individual participant data available to researchers outside the study.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2036, 120 months later.
Of 61 phase 3 interventional studies under Coronary Artery Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 58. This study's planned 120 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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