Effect of Point-of-care Analysis of Ultrasensitive Troponin I on Length of Hospital Stay in Patients With Cardiac Chest Pain: a Randomized Study (POC Troponina)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time between admission of a patient with chest pain symptoms to the emergency department of the Heart Institute-HCFMUSP and discharge after diagnosis of ACS-NSTE.
研究概览
简要总结
This clinical study aims to compare two different methods for measuring high-sensitivity troponin I, a key biomarker used to diagnose heart attacks.
The primary research question is: Does the use of the Atellica VTLi kit from Siemens for high-sensitivity troponin I (hs-cTnI) testing at the point of care (POC) significantly reduce the average time from admission to hospital discharge compared to the conventional laboratory methodology using the Alinity i kit from ABBOTT?
Participant will:
- Patients aged ≥ 18 years.
- Patients arriving in the emergency room with symptoms suggestive of ACS, with onset of pain between 3 and 12 hours after arrival, in whom serial troponin dosing is planned for investigation.
- Signature of the Informed Consent Form (ICF).
Researchers will analyze whether the point-of-care testing method helps speed up the hospital discharge process compared to the standard laboratory approach. They will also compare the accuracy of the test results, the time taken for clinical decisions, and the overall cost-effectiveness of the two methods.
详细描述
Objective: evaluation of the length of hospital stays for patients with chest pain in the Emergency Unit of the Heart Institute-HCFMUSP, comparing two methods of ultrasensitive troponin I dosage: the Atellica VTLi kit from Siemens, used in the point of care methodology, and the Alinity i kit from ABBOTT, used in the local laboratory. The aim is to compare the time elapsed between admission and discharge in the two groups, seeking to identify possible differences in the efficiency and speed of care provided by each method.
Background: cardiovascular diseases (CVD) continue to be the main cause of mortality and morbidity in patients admitted to the emergency room with chest pain. Among CVDs, ischemic heart disease is the most lethal, accounting for 38% of all CVD deaths in women and 44% in men. Diagnosis in these cases must be rapid and efficient, since the prognosis improves significantly when treatment is started early in patients with ACS.
Study design: randomized, open, comparative and parallel study at a single center.
Sample size: 200 patients
Intervention: eligible patients will be randomized 1:1 into two groups: the POC dosage group and the control group. In both groups, samples will be taken at time zero and after 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years.
- •Patients arriving in the emergency room with symptoms suggestive of ACS, with onset of pain between 3 and 12 hours after arrival, in whom serial troponin dosing is planned for investigation.
- •Signature of the Informed Consent Form (ICF).
排除标准
- •Patients presenting with ACS with ST-segment elevation on the 12-lead ECG on arrival at hospital.
- •Patients with conditions that interfere with the interpretation of troponin dosage (chronic renal failure, cancer, chronic lung diseases).
- •Pregnant or breastfeeding patients.
- •Patients already included in other clinical research protocols.
研究组 & 干预措施
POC Group
For patients randomized to the POC group, the Siemens Atellica VTLi kit will be used. This hs-cTnI test employs a two-site sandwich immunoassay, where anti-cTnI antibodies conjugated to paramagnetic particles bind to cTnI. The particles are manipulated by magnetic fields, allowing optical detection. The biomarker concentration is calculated using a calibration curve.
The primary sample is whole capillary blood, collected by fingertip puncture. Additionally, patients will have venous ultrasensitive troponin collected using the local laboratory.
Reference values (99th percentile, pg/mL): Women: 18.5 - Men: 27.1.
The cTnI values between 0 and LoD are reported as <LoD; values above 1250 pg/mL as >1250 pg/mL. Samples will be taken at times 0 and 1 hour. Analysis will follow the manufacturer's guidelines.
干预措施: Point-of-care ultrasensitive troponin testing (Diagnostic Test)
Control Group
For patients randomized to the ultrasensitive troponin dosing arm using the local laboratory, the ABBOTT Alinity i kit will be used. Samples will be taken at 0 and 1 hour after admission. The sample for this analysis will be collected by venipuncture and should be drawn into serum tubes with a separator (5 mL capacity).
The Alinity i STAT High Sensitive Troponin-I assay is a chemiluminescence microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in serum and plasma using the Alinity i analyzer. The analysis will be conducted following the manufacturer's instructions. The measurement range of the assay is 10 to 50,000 pg/mL.
Population reference values (99th percentile, pg/mL):
Women (21-75 years): 15.6 Men (21-73 years): 34.2
干预措施: Laboratory-based ultrasensitive troponin testing (Diagnostic Test)
结局指标
主要结局
Time between admission of a patient with chest pain symptoms to the emergency department of the Heart Institute-HCFMUSP and discharge after diagnosis of ACS-NSTE.
时间窗: 30 days
From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach.
次要结局
- Differences in ultrasensitive troponin values obtained by the two methods(At the time of randomization (0-hour) and at 1 hour)
- Differences between time from admission to diagnosis of NSTE ACS(30 days)
- Compare the time between blood collection and the result for both groups(4 hours)
- Determine the time to hospital discharge for patients where ACS has been ruled out (normal hs troponin values)(24 hours)
- Comparing major adverse cardiovascular events (MACE)(30 days)
- Comparison of the cost-effectiveness of the two diagnostic methods for ultrasensitive troponin measurement(30 days)
研究者
Ludhmila Abrahão Hajjar MD, PhD
Full Professor of Emergency Medicine
University of Sao Paulo