The Use of Cardiovascular Biomarkers in Abdominal Aortic Surgery

NCT02122497 | Unknown

• 1 other identifier: BIAS1.0
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is the evaluation of cardiovascular biomarkers in patients with abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome. By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification by assessment of cardiac stress tolerance. Data gathered may help to simplify the decision whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be performed. Study Hypothesis: The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP, hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.

Conditions

Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases

Keywords

abdominal aortic aneurysm; aortic occlusive disease; cardiovascular biomarkers; open surgical repair; endovascular aortic repair

Outcome Measures

Primary Outcomes (1)

• cardiovascular morbidity and mortality

  up to five years

Secondary Outcomes (1)

• all cause mortality

  up to five years

Study Arms (3)

abdominal aortic aneurysm (AAA) endovascular

endovascular aortic repair

Procedure: abdominal aortic surgery

abdominal aortic aneurysm (AAA) open

open surgical repair

Procedure: abdominal aortic surgery

abdominal aortic occlusive disease (AOD)

open surgical repair

Procedure: abdominal aortic surgery

Interventions

abdominal aortic surgery PROCEDURE

Also known as: Open surgical repair (OR), Endovascular aortic repait (EVAR)

abdominal aortic aneurysm (AAA) endovascular; abdominal aortic aneurysm (AAA) open; abdominal aortic occlusive disease (AOD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from abdominal aortic aneurysm or abdominal aortic occlusive disease scheduled either for open surgical repair or endovascular procedure

You may qualify if:

• abdominal aortic aneurysm
• peripheral aortic occlusive disease
• age \> 18 years
• approval to participate

You may not qualify if:

• absence of clearing for surgery
• canceled surgery
• unability or refusal to participate
• lack of complete follow-up

Sponsors & Collaborators

• Prim PD Dr Afshin Assadian: lead
• Wilhelminenspital Vienna: collaborator

Study Sites (1)

Department of Vascular and Endovascular Surgery, Wilhelminenhospital

Vienna, Vienna, 1160, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Afshin Assadian, PD Dr.

  Department of Vascular and Endovascular Surgery, Wilhelminenhospital Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edda Skrinjar, MD

CONTACT

00431491504107; edda.skrinjar@wienkav.at

Afshin Assadian, MD

CONTACT

00431491504101; afshin.assadian@wienkav.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prim PD Dr

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

AU (1)