Clinical trial NCT03105427: Leukocytes and Cardiovascular Perioperative Events-2
Official title: Assoziationen Von Leukozyten-Sub-Populationen im Blut kardiovaskulärer Risikopatienten Mit Der Inzidenz Perioperativer kardiovaskulärer Ereignisse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Non-cardiac Surgery
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to University Hospital Heidelberg suffering coronary heart disease and scheduled for major non-cardiac surgery

Brief summary: The potential use of regulatory T cells as preoperative risk stratification tool is evaluated in order to improve clinical risk stratification and reduce perioperative morbidity and mortality.

Detailed description: Annually, there are more than 200 million surgeries worldwide. The POISE study revealed 5% of patients undergoing a non-cardiac surgery suffer perioperative myocardial infarcts going along with a perioperative mortality rate of about 11,6%. Possibilities to preoperatively identify patients at risk are limited and prophylactic interventions are not yet established or controversial.

Selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events.

The aim of this study is to evaluate the potential use of regulatory T cells as preoperative risk stratification tool in order to improve clinical risk stratification and reduce perioperative morbidity and mortality. Therefore, high-risk cardiovascular patients scheduled for major non-cardiac surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Leukocytes will be analyzed by flow cytometry. During 30 day follow up adverse cardiovascular events will be recorded. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to the operation and on post-OP day one to three. The patient chart will be screened for cardiovascular events up to day 30. A telephone interview will be performed to detect cardiovascular events after discharge until post-OP day 30.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Coronary heart disease
* Non-cardiac surgery
* Inpatient treatment
* Informed consent

Exclusion Criteria:

* 17 years of age or younger
* Known pregnancy or breastfeeding
* Missing informed consent
* Ambulatory or day-case surgery
* Emergency surgery
* Acute or chronic leukemia
* Current aplasia or leukopenia
* Current GM-CSF treatment
* Carotid artery surgery
* History of splenectomy
* Current intravenous or oral Cortisone treatment
* History of organ transplantation
* Current immunosuppressive medication
* Chemotherapy completed less than 14 days ago
* Entity which is part of the composite endpoint diagnosed within past 28 days

Primary outcomes:
measure: Cardiovascular Events
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Peripheral vascular occlusion
timeFrame: 30 days postoperative
measure: New onset atrial fibrillation
timeFrame: 30 days postoperative
measure: Acute kidney injury
timeFrame: 30 days postoperative
measure: Congestive heart failure
timeFrame: 30 days postoperative
measure: Cardiac death
timeFrame: 30 days postoperative
measure: Myocardial Ischemia
timeFrame: 30 days postoperative
measure: Myocardial Infarction
timeFrame: 30 days postoperative
measure: Myocardial Injury after Non-cardiac Surgery (MINS)
timeFrame: 30 days postoperative
measure: Stroke
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Anaesthesiology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
References:
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