Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 10:12 PM
Study NCT ID:
NCT04223934
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2020-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Drug Titration Using Artificial Intelligence
Sponsor:
Optima Integrated Health
Organization:
Study Overview
Official Title:
ARTERY Outcomes: Tailored Drug Titration Through Artificial Intelligence - an Interventional Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the ARTERY Outcomes study is to compare optima-for-blood pressure (optima4BP), a clinical decision support system for hypertension (HTN) treatment optimization to standard of care in patients with essential HTN.
Detailed Description:
Nearly 34 million Americans have their blood pressure (BP) uncontrolled. Hypertension (HTN) claims 1000 deaths every day. Despite medication and life-style management, the cost of HTN associated hospitalizations had escalated to $113 billion in 2016, or 15% of all hospital costs, with \>135 million Emergency Department (ED) visits.
Uncontrolled HTN for even a few weeks is associated with increased risk for acute cardiovascular (CVD) events \[stroke, heart failure (HF), myocardial infarction (MI)\] and death. Medication treatment optimization to BP goal reduces the incidence of stroke by 35-40%, HF by up to 64%, and MI by 15-25%.
optima-for-blood pressure \[optima4BP\] transforms the episodic and reactive nature of uncontrolled HTN pharmacological treatment management into a process that is continuous, proactive, and personalized. The innovation simulates the established clinical reasoning treatment decision process undertaken during a patient's visit.
Uncontrolled HTN for even a few weeks is associated with increased risk for acute cardiovascular (CVD) events \[stroke, heart failure (HF), myocardial infarction (MI)\] and death. Medication treatment optimization to BP goal reduces the incidence of stroke by 35-40%, HF by up to 64%, and MI by 15-25%.
optima-for-blood pressure \[optima4BP\] transforms the episodic and reactive nature of uncontrolled HTN pharmacological treatment management into a process that is continuous, proactive, and personalized. The innovation simulates the established clinical reasoning treatment decision process undertaken during a patient's visit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: