Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases

Sponsor
Universidade Nova de Lisboa (Other)
Overall Status
Completed
CT.gov ID
NCT04786431
Collaborator
Hospital Santa Cruz, Centro Hospitalar de Lisboa Ocidental (Other), Department of Neurology, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental (Other), Hospital Dr. Fernando da Fonseca (Other), Lipotype GmbH, Tatzberg 47, 01307, Dresden, Germany. (Other), iNOVA4Health, CEDOC, NOVA Medical Schoo (Other), Fundação para a Ciência e a Tecnologia (FCT) (Other)
427
72

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Blood collection for lipid profiling by LC-MS

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.

Study Design

Study Type:
Observational
Actual Enrollment :
427 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Controls, CVD, IS, SLE

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. 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.

Other: Blood collection for lipid profiling by LC-MS
Blood withdrawal

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of inflammatory disease [Day 1: Age, height, weight, sex, statin use and lipid level in plasma]

    Controls never had any CVD- or SLE-related health complaints. CVD1 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 are patients with stable angina pectoris (SAP). CVD1 and CVD2 are defined according to the ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guidelines. CVD3 contains patients with unstable angina pectoris, CVD4 are patients who suffered an acute myocardial infarction with no ST-elevation in ECG, and CVD5 are patients who suffered acute myocardial infarction with ST-elevation in ECG . Acute ischemic stroke (IS) were patients admitted at the emergency room of the Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal SLE cohort were patients from Hospital Dr. Fernando Fonseca, Amadora, Portugal.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidade Nova de Lisboa
  • Hospital Santa Cruz, Centro Hospitalar de Lisboa Ocidental
  • Department of Neurology, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental
  • Hospital Dr. Fernando da Fonseca
  • Lipotype GmbH, Tatzberg 47, 01307, Dresden, Germany.
  • iNOVA4Health, CEDOC, NOVA Medical Schoo
  • Fundação para a Ciência e a Tecnologia (FCT)

Investigators

  • Principal Investigator: Otília Vieira, PhD, iNOVA4Health, CEDOC, NOVA Medical School, NMS, Universidade Nova de Lisboa, 1169-056 Lisboa, Portugal

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universidade Nova de Lisboa
ClinicalTrials.gov Identifier:
NCT04786431
Other Study ID Numbers:
  • UniversidadeNL_29395
First Posted:
Mar 8, 2021
Last Update Posted:
Mar 8, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidade Nova de Lisboa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2021