A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O- H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503843-33-00

Acronym

MedTrace-002

Enrollment

182

Registered

2023-05-09

Start date

2022-05-04

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Coronary Artery Disease

Brief summary

The primary efficacy endpoints of the study are the sensitivity and specificity of 15O-H2O Injection PET MPI in the detection of significant CAD. The truth standard used in this study is the presence of clinically significant CAD as assessed by either ICA, ICA with FFR or CCTA.

Detailed description

None

Interventions

DRUGO15-Water

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoints of the study are the sensitivity and specificity of 15O-H2O Injection PET MPI in the detection of significant CAD. The truth standard used in this study is the presence of clinically significant CAD as assessed by either ICA, ICA with FFR or CCTA.	—

Secondary

Measure	Time frame
None	—

Countries

Denmark, Germany, Netherlands, Sweden

Outcome results

None listed

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