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NCT04270630

A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMI

Completed NA Last updated 3 July 2023
What this trial tests

NA trial testing Shared Decision Aid in NSTEMI in 14 participants. Completed in 1 December 2022.

Timeline
1 July 2020
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorNYU Langone Health
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date1 July 2020
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

NYU Langone Health — full company profile →

Who can join

75 and older, any sex, with NSTEMI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be a single-center, prospective, un-blinded, randomized controlled trial evaluating a decision aid tool for older patients considering left heart catheterization (LHC) as treatment for non-ST elevation myocardial infarction (NSTEMI). The study population is 50 total inpatients (25 per study arm) with NSTEMI eligible for elective LHC. The first arm is the control group that will receive standard of care, while the second arm will have access to the decision aid and shared-decision making conversation with one of the co-investigators. Baseline characteristics and surveys/questionnaire data will be collected after study intervention (as applicable), and prior to final decision regarding LHC. Statistical analyses will be conducted on the primary endpoint, decisional conflict score, as well as on various secondary endpoints.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Decision aids for people facing health treatment or screening decisions.
    Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6

Verify or expand the search:

Other recruiting trials for NSTEMI

Currently open trials in the same condition.

Other NYU Langone Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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