Prognostic Value of Oxygen-15 Water PET in Coronary Artery Disease
NCT07932314, Phase 3, Recruiting, Vastra Gotaland Region
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prognostic Value of Oxygen-15 Water PET in Coronary Artery Disease | ClinicalTrials.gov |
| NCT number | NCT07932314 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 40,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Vastra Gotaland Region | ClinicalTrials.gov |
| Conditions | Coronary Artery Disease, Microvascular Coronary Artery Disease, Microvascular Coronary Dysfunction | ClinicalTrials.gov |
| Interventions | Oxygen-15 Water | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prognostic Thresholds of Stress Myocardial Blood Flow for Predicting MACE-1 (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Primary | Prognostic Thresholds of Rest Myocardial Blood Flow for Predicting MACE-1 (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Primary | Prognostic Thresholds of Myocardial Flow Reserve for Predicting MACE-1 (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Secondary | Subgroup-Specific Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting MACE-1 (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Secondary | Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting MACE-2 (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Secondary | Subgroup-Specific Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting MACE-2 (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Secondary | Prognostic Thresholds of Myocardial Blood Flow and Myocardial Flow Reserve for Predicting Individual Cardiovascular and Non-Cardiovascular Events (Main Basket) | 2 and 5 years after the PET examination | 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). | ClinicalTrials.gov |
| Other | Change in Myocardial Blood Flow and Myocardial Flow Reserve Over Time (Additional Baskets) | Baseline and follow-up (2 - 14 months after the baseline PET examination, depending on basket) | 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). | ClinicalTrials.gov |
| Other | Novel and Established Cardiovascular Biomarkers in Relation to Myocardial Perfusion (All Baskets) | Up to 15 years after the last PET scan | 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. | ClinicalTrials.gov |
| Other | SAEs and SUSARs Within 24 Hours of Oxygen-15 Water Administration (All Baskets) | Within 24 hours after oxygen-15 water administration | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)