Clinical trial NCT04786431: Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases
Official title: Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomarker
Lipid
Inflammation
Cardiovascular Diseases
Ischemic Stroke
Systemic Lupus Erythematosus
Healthy
Keywords: Mass spectromtry
Lipidomics
cardiovascular disease
Machine learning
Regression models
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Hospital Santa Cruz, Centro Hospitalar de Lisboa Ocidental
name: Department of Neurology, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental
name: Hospital Dr. Fernando da Fonseca
name: Lipotype GmbH, Tatzberg 47, 01307, Dresden, Germany.
name: iNOVA4Health, CEDOC, NOVA Medical Schoo
name: Fundação para a Ciência e a Tecnologia (FCT)
First posted: 2021-03-08
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls were from the population of the Coimbra and Lisbon, Portugal, regions. They satisfied the criterion that they had never had any CVD- or SLE-related health complaints. CVD1 (n= 61) contains individuals who went to the hospital with chest pain but had no indicators for stable angina pectoris, unstable angina pectoris or myocardial infarction. CVD2 (n=82) are patients with stable angina pectoris. CVD3 (n=20) contains patients with unstable angina pectoris, CVD4 (n=34) are patients who suffered an acute myocardial infarction with no ST-elevation in ECG, and CVD5 (n= 20) are patients who suffered acute myocardial infarction with ST-elevation in ECG. CVD1 through CVD5 groups were from Hospital Santa Cruz, Carnaxide, Portugal. IS (n=21) were patients admitted at the emergency room of the Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal, who suffered from acute ischemic stroke. The SLE cohort (n=104) were patients from Hospital Dr. Fernando Fonseca, Amadora, Portugal.

Brief summary: Collect blood from patients admitted for coronary angiography to tubes with heparin, centrifuge and collect plasma. This will be frozen at -80C. Sent to the Lipotype laboratory, Dresden, Germany, for the detection and quantification of compounds derived from oxidized LDL cholesterol (cholesterol hemi-esters).

Detailed description: Plasma samples were obtained from a total of 427 individuals. Baseline characteristics are outlined in Table 1. Control (n = 85) were taken from the population of the Coimbra and Lisbon, Portugal, regions. They satisfied the criterion that they had never had any CVD- or SLE-related health complaints. The CVD patients (n = 238) were divided into 6 groups. CVD1 (n = 61) contains individuals who went to the hospital with chest pain but had no indicators for stable angina pectoris, unstable angina pectoris or myocardial infarction. CVD2 (n = 82) are patients with stable angina pectoris (SAP). CVD1 and CVD2 are defined according to the ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guidelines. CVD3 (n = 20) contains patients with unstable angina pectoris, CVD4 (n = 34) are patients who suffered an acute myocardial infarction with no ST-elevation in ECG, and CVD5 (n = 20) are patients who suffered acute myocardial infarction with ST-elevation in ECG. CVD3, CVD4, and CVD5, together, may be classified as patients with an acute coronary syndrome (ACS). CVD1 through CVD5 groups were all obtained from Hospital Santa Cruz, Carnaxide, Portugal. Acute ischemic stroke (IS) (n = 21) were patients admitted at the emergency room of the Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal, who suffered from acute ischemic stroke. The SLE cohort (n = 104) were patients from Hospital Dr. Fernando Fonseca, Amadora, Portugal. The inclusion criteria were all patients diagnosed with the pathology and above 18 years old. The exclusion criteria were the existence of serious renal and hepatic pathologies, cancer or existence of infectious diseases.

Eligibility criteria: Inclusion Criteria:

* Patients admitted for coronary angiography due to suspected coronary disease (silent ischemia, stable angina and acute coronary syndromes)

Exclusion Criteria:

* Patients unable to give informed consent

Primary outcomes:
measure: Diagnosis of inflammatory disease
timeFrame: Day 1: Age, height, weight, sex, statin use and lipid level in plasma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: iNOVA4Health, CEDOC, NOVA Medical School, NMS, Universidade Nova de Lisboa, 1169-056 Lisboa, Portugal
name: Otília Vieira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
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