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NCT01383382 · ClinicalTrials.gov registry record

Transforming PCI Informed Consent Into an Evidence-based Decision-making Tool

A clinical trial, sponsored by Saint Luke's Health System.

Completed
Registry status
1,399
Enrollment target

NCT01383382 is a clinical trial that has completed, run by Saint Luke's Health System. The registered enrollment target is 1,399 participants.

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The verdict

NCT01383382 has completed, sponsored by Saint Luke's Health System.

COMPLETED
Registry status
1,399 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 1,399 participants
Start Date 2009-09
Est. Completion 2012-09

Sponsor

Saint Luke's Health System

26 total trials

What the Registry Record Tells You About NCT01383382

The ClinicalTrials.gov registry entry for NCT01383382 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,399 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Saint Luke's Health System, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01383382 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01383382 about?

NCT01383382 is a clinical study titled "Transforming PCI Informed Consent Into an Evidence-based Decision-making Tool". 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-b...

What is the current status of trial NCT01383382?

This trial is currently completed. The enrollment target is 1,399 participants. The study started on 2009-09. Estimated completion is 2012-09.

Who is sponsoring clinical trial NCT01383382?

This trial is sponsored by Saint Luke's Health System, which has 26 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.