Hospital Israelita Albert Einstein
SITE-CV-118-006
PausedWatch · 46
Enrolled
274
Screen fail %
31.6%
Open queries
11
Risk score
52
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. Beatriz Almeida
- Site coordinator
- Sao Site Coordinator
- Monitor (CRA)
- CRA — Brazil region
Recent activity
| Date | Kind | Summary | Actor |
|---|---|---|---|
| 2026-09-10 | Enrollment | New subject enrolled (Subject 0042) | Dr. Beatriz Almeida |
| 2026-09-07 | Monitoring visit | CRA monitoring visit completed; 12 SDV checks closed | CRA team |
| 2026-09-03 | Query resolved | Two open queries resolved by site coordinator | Site coordinator |
| 2026-08-29 | Signature | Protocol amendment v3 signed by PI | Dr. Beatriz Almeida |
| 2026-08-22 | Query opened | Data management opened query on AE form (Subject 0031) | Data management |
Deviation history
| Date | Severity | Title | CAPA | Status |
|---|---|---|---|---|
| 2026-08-13 | minor | Informed consent re-consent window exceeded | Site retrained on v3 protocol; tracker added. | open |
| 2026-07-14 | major | Visit window exceeded by >7 days for two subjects | CRA flagged subjects; both within protocol-allowed window after review. | under-review |