Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases

Healthy Clinical Trial

Official title:

Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786431
• Other study ID #: UniversidadeNL_29395
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarker
• Cardiovascular Diseases
• Healthy
• Inflammation
• Ischemic Stroke
• Lipid
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (7)

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

References & Publications (3)

Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. Erratum in: Circulation. 2014 Dec 23;130(25):e431-2. Dosage error in article text. — View Citation

Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease: Executive Summary: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 Dec 18;60(24):2564-603. doi: 10.1016/j.jacc.2012.07.012. Epub 2012 Nov 19. — View 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. Erratum in: Circulation. 2018 Nov 13;138(20):e652. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of inflammatory disease	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