Clinical trial NCT03825094: DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry
Official title: DyeVert™ System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients at Risk for Developing Contrast-induced Nephropathy
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2019-01-31
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DyeVert Systems are indicated for patients undergoing angiographic procedures requiring injection of contrast media. Patients at risk for developing contrast-induced nephropathy (CIN) represent the target population for these devices.

Brief summary: The purpose of this registry-based study is to evaluate the ongoing, real-world clinical performance and safety of commercially available DyeVert Systems during typical clinical use for patients undergoing coronary or peripheral angiography for diagnostic and/or interventional procedures.

Detailed description: Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary angiography and is associated with increased morbidity, mortality, and healthcare costs. Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media volume (CMV) to the patient during angiography; however, hospitals face barriers to implementation in the real-world setting and therefore consistent care delivery for at-risk patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV monitoring and minimization during angiography procedures thereby reducing total CMV to the patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI. The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and safety of commercially available DyeVert Systems among a large, real-world population of patients undergoing coronary and peripheral angiography.

Eligibility criteria: Inclusion Criteria:

* DyeVert Group Patients: Patient underwent a diagnostic and/or interventional angiography procedure in which the DyeVert System was used in a majority of the case
* Patient is willing and able to provide appropriate informed consent (if required)

Exclusion Criteria:

* Required data was not collected or is not available
* In the Investigator or Sponsor's opinion, the patient is not considered to be suitable

Primary outcomes:
measure: Evaluate contrast media volume (CMV) threshold setting practices and contrast media (CM) usage during index cath lab procedures in which the DyeVert System was used
timeFrame: Index procedure
measure: Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used
timeFrame: Index procedure through 120 days post index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Hialeah
country: United States
facility: Steward Palmetto General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Overland Park
country: United States
facility: Midwest Heart & Vascular Specialists
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: CHRISTUS Health-Westover Hills
state: Texas
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory
name: Anand Prasad, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: