Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases

March 5, 2021 updated by: Universidade Nova de Lisboa
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of inflammatory disease
Time Frame: 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.
Day 1: Age, height, weight, sex, statin use and lipid level in plasma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniversidadeNL_29395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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