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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27132
Enrollment
1800
Registered
2007-02-25
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cardiac surgery, NT-proBNP, Perioperative cardiac complications

Interventions

Patients scheduled for major vascular surgery (i.e. aorta-iliac /femoral and femoro-popliteal/crural bypass operation) will be screened for the following cardiac risk factors: age>70 years
a history or symptoms of angina pectoris
a history of myocardial infarction (history and/ or presence of Q-wave on ECG)
a history of congestive heart failure
diabetes mellitus
renal dysfunction (serum creatinine>180 µmol/l) or a history of cerebrovascular accident. The value of each cardiac risk factor is the same. In all patients without and those with one or two risk fact
2) surgery with optimal medical cardioprotection or 3) prophylactic coronary revascularization. The type of coronary revascularization, bypass surgery or percutaneous coronary

Sponsors

Erasmus Medical Center, Department of Anesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with peripheral vascular atherosclerosis scheduled for vascular surgery involving either: a. revascularization utilizing aortic or proximal lower extremity procedures, or b. distal lower extremity vascular reconstruction, are eligible to participate.

Exclusion criteria

Exclusion criteria: 1. Emergency surgical procedures; 2. Unability or unwillingness to provide written informed consent; 3. Previous participation in this same trial; 4. Concurrent participation in another clinical trial; 5. Contraindication for cardiac stress testing.

Design outcomes

Primary

MeasureTime frame
The primary objective of this trial is to validate the screening potential of NT-proBNP in a population of low to intermediate risk patients, i.e. patients with zero to two cardiac risk factors, scheduled for vascular surgery.—

Secondary

MeasureTime frame
The secondary objective is to identify prior to vascular surgery high risk patients, with three or more cardiac risk factors, with a normal stress test..—

Contacts

Public ContactD. Poldermans

Erasmus MC Department of Anesthesiology

d.poldermans@erasmusmc.nl+31 10 4634613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)