Association of PeriOPerative Aspirin-ResisTance and CardioVascular Outcome

NCT04053894 | Unknown

• 1 other identifier: S-468/2019
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the association between perioperative aspirin resistance and Myocardial Injury after Non-cardiac Surgery (MINS) in patients undergoing vascular surgery.

Conditions

Vascular Surgery

Keywords

vascular surgery; aspirin resistance; MINS

Outcome Measures

Primary Outcomes (1)

• Myocardial Injury after Non-cardiac Surgery

  Number of participants with MINS defined as raise in postoperative hs-cTNT (high sensitivity cardiac troponin T) judged due to myocardial ischemia detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days.

  30 days postoperative

Secondary Outcomes (11)

• Composite of Cardiovascular Events

  30 days postoperative

• Peripheral vascular occlusion

  30 days postoperative

• Mesenteric ischemia

  30 days postoperative

• New-onset atrial fibrillation

  30 days postoperative

• Congestive heart failure

  30 days postoperative

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 on aspirin treatment, admitted to University Hospital Heidelberg and scheduled for vascular surgery.

You may qualify if:

• years or older
• Preoperative aspirin treatment at least 14 days prior to surgery
• Elective vascular surgery
• In-patient treatment
• Informed consent

You may not qualify if:

• years of age or younger
• Known pregnancy or breastfeeding
• Missing informed consent
• Ambulatory or day-case surgery
• Emergency surgery
• Current clopidogrel or non-steroidal anti-inflammatory drug treatment
• Preoperative aspirin resistance
• Current thrombocytopenia (\<100000 platelet/µl)
• Liver or renal failure (GOT/GPT and/or creatinine increased \>2-fold)
• Entity which is part of the composite endpoint diagnosed within past 28 days
• Angiography without surgical intervention

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (14)

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• Gillmann HJ, Meinders A, Grohennig A, Larmann J, Bunte C, Calmer S, Sahlmann B, Rustum S, Aper T, Lichtinghagen R, Koch A, Teebken OE, Theilmeier G. Perioperative levels and changes of high-sensitivity troponin T are associated with cardiovascular events in vascular surgery patients. Crit Care Med. 2014 Jun;42(6):1498-506. doi: 10.1097/CCM.0000000000000249.

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• Gillmann HJ, Meinders A, Larmann J, Sahlmann B, Schrimpf C, Aper T, Lichtinghagen R, Teebken OE, Theilmeier G. Adrenomedullin Is Associated With Surgical Trauma and Impaired Renal Function in Vascular Surgery Patients. J Intensive Care Med. 2019 Jan;34(1):67-76. doi: 10.1177/0885066616689554. Epub 2017 Jan 23.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma samples

Study Officials

• Jan Larmann, MD PhD

  Departement of Anaesthesiology, Heidelberg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Larmann, MD PhD

CONTACT

06221/5639447; jan.larmann@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)