Do medicines that lengthen the heart's QT interval cause serious heart problems in hospitalized adults?
Do 'Known' QT-prolonging Medications Cause Major Adverse Cardiac Events in Hospitalized Adults? The QTP-MACE Study
This project will test whether commonly used hospital medicines that can prolong the heart's QT interval lead to serious cardiac events in adults admitted to Ontario hospitals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 990000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT07374263 on ClinicalTrials.gov |
What this trial studies
Researchers will use anonymized electronic medical record data from the Ontario GEMINI network and Epic‑Dovetale, covering more than 990,000 eligible adult hospital admissions, to compare patients who experienced a major adverse cardiac event (MACE) with those who did not. The team will perform a nested case‑control analysis and time-varying exposure analyses to measure whether exposure to listed 'known' QT‑prolonging medications during hospitalization is associated with a composite MACE outcome of death, non-fatal cardiac arrest, ventricular arrhythmia, or syncope. In addition, machine‑learning algorithms will be trained to predict QTPmed-associated MACE and to determine the relative importance of predictors. Results will be used to improve the accuracy and clinical usefulness of medication safety alerts.
Who should consider this trial
Good fit: Ideal candidates are adults (18 years or older) admitted to St. Joseph's Healthcare Hamilton or GEMINI-affiliated hospitals between December 2017 and March 2025 whose anonymized inpatient records are included in the EMR datasets.
Not a fit: Children under 18, outpatient encounters, and patients treated outside the participating hospitals or outside the specified date range are not included and therefore will not directly benefit from this project.
Why it matters
Potential benefit: If successful, the findings could make QT‑prolonging medication alerts more accurate, reduce unnecessary clinician interruptions and burnout, and help prevent some serious cardiac events.
How similar studies have performed: Existing evidence linking many listed 'known' QT‑prolonging drugs to major cardiac events is sparse and low-quality, so this large EMR and machine‑learning approach is relatively novel and aims to provide stronger evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients 18 years of age or older * Admitted to St. Joseph's Healthcare Hamilton or GEMINI hospitals between December 2017 and March 2025 Exclusion Criteria: * Patients \<18 years old * Outpatient encounters
Where this trial is running
Hamilton, Ontario and 1 other locations
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
- Gemini — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Anne M Holbrook — St. Joseph's Healthcare Hamilton
- Study coordinator: Anne M Holbrook, MD,PharmD,MSc,FRCPC
- Email: cptres@mcmaster.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.