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Toronto General Hospital

SITE-CV-118-005

ClosedHealthy · 14

Enrolled

318

Screen fail %

27.0%

Open queries

2

Risk score

16

Months active

64

Study assignment

Sponsor
Helios Cardio
Study code
CV-118
Therapeutic area
Cardiovascular
Indication
Reduction of MACE in post-MI patients with elevated Lp(a)

Staffing

Principal investigator
Dr. Nathan Singh
Site coordinator
Toront Site Coordinator
Monitor (CRA)
CRA — Canada region

Recent activity

DateKindSummaryActor
2026-09-10EnrollmentNew subject enrolled (Subject 0042)Dr. Nathan Singh
2026-09-07Monitoring visitCRA monitoring visit completed; 12 SDV checks closedCRA team
2026-09-03Query resolvedTwo open queries resolved by site coordinatorSite coordinator
2026-08-29SignatureProtocol amendment v3 signed by PIDr. Nathan Singh
2026-08-22Query openedData management opened query on AE form (Subject 0031)Data management

Deviation history

DateSeverityTitleCAPAStatus
2026-08-13minorInformed consent re-consent window exceededSite retrained on v3 protocol; tracker added.open