interventional
N/A
1 country
1
The primary objective for the main basket cohort is to determine prognostic thresholds for predicting major adverse cardiovascular events-1 (MACE) in participants with clinically suspected or known CAD, using quantitative H2[15O] PET-derived absolute global and regional MBF at rest and during pharmacological stress (ml/min/g), as well as MFR, to discriminate between high- and low-risk individuals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2026
Actual (reported)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.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Adenosin Life Medical 5 mg/ml, Injektions-/infusionsvätska, lösning.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
Rapiscan 400 microgram solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Adenosin Life Medical 5 mg/ml, Injektions-/infusionsvätska, lösning.
Named ingredient: Adenosine
View registry recordRapiscan 400 microgram solution for injection
Named ingredient: regadenoson
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Goteborg, 413 46, Sweden
Christian Polte
First Submitted
April 14, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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