A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery

Roche

Status: Unknown

Conditions: Peripheral Vascular Disease

Treatments: Device: Elecsys®proBNP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519961

RD000485

DECREASE-VI

Details and patient eligibility

About

The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥18 years of age
• Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery

Exclusion criteria

• N/A

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 2 patient groups

A

Experimental group

Treatment:

Device: Elecsys®proBNP

B

Experimental group

Treatment:

Device: Elecsys®proBNP