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BiomarkerNCT04786431

Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases

An observational study of Biomarker and Lipid, run by Universidade Nova de Lisboa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biomarker, Lipid, Inflammation
What is being tested?
Blood collection for lipid profiling by LC-MS
How many people
427 participants
Where
No sites listed yet
Study dates
1 Mar 2015to 1 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Patients unable to give informed consent

About this study

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).

Read the 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.

Being tested
Blood collection for lipid profiling by LC-MS
Keywords
Mass spectromtry, Lipidomics, cardiovascular disease, Machine learning, Regression models
Medical subject headings
Inflammation, Cardiovascular Diseases, Ischemic Stroke, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood collection for lipid profiling by LC-MSOther

    Blood withdrawal

Study groups in NCT04786431
Study groupRoleWhat they receive
Controls, CVD, IS, SLEControl (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.
Receives: Other: Blood collection for lipid profiling by LC-MS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1: Age, height, weight, sex, statin use and lipid level in plasma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start1 Mar 2015
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04786431
Sponsor's protocol ID
UniversidadeNL_29395
Status last verified
Mar 2021
First submitted
2 Mar 2021
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. No abstract available.

    PubMed 23182124

  • 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.

    PubMed 30571511

  • 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. No abstract available.

    PubMed 25249586

Questions about this trial

What is this clinical trial studying?

An observational study of Biomarker and Lipid, run by Universidade Nova de Lisboa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of inflammatory disease (time frame: Day 1: Age, height, weight, sex, statin use and lipid level in plasma). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786431, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.

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