Protect: Clinical evaluation of pacing during the onset of revascularization. Clinical feasibility study

Protect: Clinical evaluation of pacing during the onset of revascularization. Clinical feasibility study - Protect

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30431

Enrollment

Registered

2006-11-10

Start date

2006-12-12

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

acute myocardial infarction heart attack

Interventions

All patients receive a primary PCI (standard treatment). The therapy group will be ventricular paced during PCI. The control group, PCI will be performed using standard clinical practice. Following

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients presenting with their first clinically documented MI in whom the clinical decision was made to treat with PCI patients older than 17 years patients in whom the time from symptom onset to hospital admission is minimal 1 hour - maximal 6 hours patients willing and capable of providing informed consent

Exclusion criteria

Exclusion criteria: patients receiving thrombolytics upon clinical presentation patients having previous unstable angina or ACS patients having a previous PCI and/or CABG clinically and hemodynamically unstable requiring circulatory support Patients with a history of VF Patients with a heartrate above 120 bpm at the time of enrollment

Design outcomes

Primary

Measure	Time frame
primary objective of this study is to assess the impact of pacing during the onset of PCI on infarct size.	—

Secondary

Measure	Time frame
secondary objective of this study are to gather data to assess the feasibility and safety of pacing during the onset of PCI.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)