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NCT05743673 · ClinicalTrials.gov registry record
SHAPE Test for Preoperative Risk Stratification
A clinical trial of Perioperative/Postoperative Complications and Aerobic Capacity, sponsored by Yale University.
- Recruiting
- Registry status
- 371
- Enrollment target
- 1
- Study location
NCT05743673 is a study of Perioperative/Postoperative Complications and Aerobic Capacity that is actively recruiting participants, run by Yale University. The registered enrollment target is 371 participants, above the 292-participant average among 8 other Perioperative/Postoperative Complications trials with a reported enrollment target (27% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05743673, a study of Perioperative/Postoperative Complications and Aerobic Capacity, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- 371 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an FDA-approved simplified cardiopulmonary exercise testing apparatus in adults \>60 years old prior to moderate to high-risk surgery. In addition, by development of a validation cohort of older adults, defined as \>60 years old, self-reporting \>4 METS and with a score of \<2 on the revised cardiac risk index (RCRI)1 we will compare its effectiveness when compared to conventional preoperative evaluation measures (METS determination by standard scoring and Duke Activity Status Index) to SHAPE™ testing.
Conditions Studied
Interventions
- DEVICE Shape II
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2023-05-03 |
| Est. Completion | 2026-05-29 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05743673
The ClinicalTrials.gov registry entry for NCT05743673 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 371 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 292-participant average among 8 other Perioperative/Postoperative Complications trials with a reported enrollment target (27% higher). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Perioperative/Postoperative Complications appearing as the primary indexed condition, and to 1 intervention - of which Shape II is the first listed.
NCT05743673 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT05743673 about?
NCT05743673 is a clinical study titled "SHAPE Test for Preoperative Risk Stratification". Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an...
What is the current status of trial NCT05743673?
This trial is currently recruiting. The enrollment target is 371 participants. The study started on 2023-05-03. Estimated completion is 2026-05-29.
What conditions does trial NCT05743673 study?
This clinical trial studies the following conditions: Perioperative/Postoperative Complications, Aerobic Capacity.
What interventions are being tested in trial NCT05743673?
The interventions under investigation include: Shape II (DEVICE).
Who is sponsoring clinical trial NCT05743673?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05743673 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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