Transforming PCI Informed Consent Into an Evidence-based Decision-making Tool
Public ClinicalTrials.gov record NCT01383382. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Using individualized patient estimates of procedural risks and benefits, this project will transform the process of informed consent for coronary angioplasty into a dynamic educational tool for patients and physicians and is a direct response to the Institute of Medicine's call for a more evidence-based, efficient, patient-centered healthcare system. It is hypothesized that patients will develop a greater understanding of their individual risks and benefits from PCI, will be empowered to more actively engage in shared decision-making, as well as have improved awareness of their responsibility to adhere to dual anti-platelet therapy if treated with a drug eluting stent (risks for target vessel revascularization with bare metal and drug eluting stents are also provided in the new consent form). It is also anticipated that physicians, in turn, will use these individualized estimates to better discriminate between risks and benefits among different bleeding avoidance therapies so as to improve the safety and cost-effectiveness of PCI.
Study identification
- NCT ID
- NCT01383382
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,399 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Sep 30, 2011
- Completion
- Aug 31, 2012
- Last update posted
- Sep 9, 2012
2009 – 2012
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente | Oakland | California | 94612 | — |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Barnes-Jewish Hospital/Washington University School of Medicine | St Louis | Missouri | 63130 | — |
| Baylor Research Institute | Plano | Texas | 75204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01383382, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2012 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01383382 live on ClinicalTrials.gov.