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Prognostic Performance of Quantitative Myocardial Perfusion Imaging Using H2[15O] Positron Emission Tomography in Coronary Artery Disease - The AQUA COR trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518706-41-01
Enrollment
40000
Registered
2026-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Brief summary

The primary endpoint of the main basket cohort is the time to first occurrence of MACE-1, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.

Detailed description

Time to first occurrence of MACE-1 in the main basket cohort, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied., Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied., Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied., Time to first occurrence of individual cardiovascular and non-cardiovascular events in the main basket cohort during a follow-up period of up to 10 years. These events include the individual components of MACE-1 and -2, hospitalization for unstable angina, hospitalization for heart failure, and unplanned ischemia-driven revascularization (PCI/CABG), with a 90-day blanking period applied to revascularization events. For risk-prediction analyses, 2- and 5-year time horizons will be applied.

Interventions

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the main basket cohort is the time to first occurrence of MACE-1, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied.

Secondary

MeasureTime frame
Time to first occurrence of MACE-1 in the main basket cohort, defined as a composite of all-cause death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied., Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied., Time to first occurrence of MACE-2 in the main basket cohort, defined as a composite of cardiovascular death and non-fatal myocardial infarction, during a follow-up period of up to 10 years. For risk-prediction analyses, 2- and 5-year time horizons will be applied., Time to first occurrence of individual cardiovascular and non-cardiovascular events in the main basket cohort during a follow-up period of up to 10 years. These events include the individual components of

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 4, 2026