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Identification of Genes Expressed in Atherosclerotic Plaque

7. september 2021 oppdatert av: National Heart, Lung, and Blood Institute (NHLBI)

Identification of Genes Expressed in Atherosclerotic Plaques

This study will identify genes and proteins in the blood of patients with atherosclerosis and in that of normal volunteers. The findings will be compared to determine the influence of these substances on the development of atherosclerosis a narrowing and hardening of blood vessel walls by deposits of fatty substances. Blood vessel blockage caused by atherosclerosis can impede blood flow and cause stroke, heart attack and poor limb circulation. The information from this study may lead to better ways to detect, prevent and treat these diseases.

Healthy volunteers and patients scheduled for carotid endarterectomy at Suburban Hospital in Bethesda, Maryland, are eligible for this study. Carotid endarterectomy is a surgical procedure in which the inner layer of the carotid artery (neck artery supplying blood to the brain) is scraped away to open the blocked vessel. Participants will undergo the following tests and procedures:

Patients

  • Blood sample: Collection of about 32 cc (8 tablespoons) of blood for genetic and protein analysis
  • Tissue sample: Collection of a piece of diseased blood vessel discarded from the endarterectomy procedure
  • Review of records: Review of medical records for information about past illnesses, medications, tests, and so forth, if needed

Normal Volunteers

  • Blood samples: Collection of about 32 cc (8 tablespoons) of blood for genetic and protein analysis
  • Carotid artery ultrasound: Ultrasound imaging of the neck arteries for detection of any blockage
  • Electrocardiogram: Recording of the electrical activity of the heart to detect any abnormalities in heart rhythm
  • Echocardiogram: Ultrasound examination to detect possible abnormalities of the heart muscle
  • Cardiac stress test: Treadmill stress test to detect possible heart vessel blockage (for subjects who have not had a cardiac stress test in the past year)
  • Review of records: Review of medical records for information about past illnesses, medications, tests, and so forth, if needed

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Significant progress has been made in the prevention and treatment of atherosclerosis, but it continues to be a leading cause of morbidity and mortality in our society. The problem will become even more significant as an increasing proportion of the population ages. The goal of the proposed project is to advance our understanding of the genetic mechanisms of atherosclerosis. We propose to identify genes selectively expressed in peripheral monocytes of patients with atherosclerosis and in macrophages and endothelial cells of atherosclerotic plaques. We will examine gene expression profiles in purified subpopulations of cells using Serial Analysis of Gene Expression (SAGE) that requires only minute amounts of RNA, enabling the study of small homogeneous populations of cells. This sequence-based high-throughput gene expression profiling technique has the advantage of not requiring prior knowledge of the expressed gene sequences, allowing the discovery of new genes. With the completion of the human genome sequence, the SAGE technique is an ideal tool for comprehensively characterizing the transcriptomes of the important cells involved in atherosclerosis. This proposal is an exploratory study to find candidates, both known and unknown genes, which will be used for more extensive and statistically powered projects in the future. The insights obtained will be used for elucidating the pathogenesis of atherosclerosis and for developing new simple, sensitive and specific tests for early disease diagnosis. In addition, the new insights obtained may lead to the development of novel therapeutic strategies for disease prevention and treatment.

Studietype

Observasjonsmessig

Registrering (Faktiske)

69

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike
      • Bethesda, Maryland, Forente stater, 20814
        • Suburban Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients

Beskrivelse

  • INCLUSION CRITERIA:

Any adult patient with carotid artery disease or known atherosclerosis capable of giving informed consent.

INCLUSION CRITERIA FOR MEDICATION TREATED SUBJECT:

Any adult with normal total cholesterol (less than 200 mg/dl) and blood pressure (systolic less than 140 and diastolic less than 90).

INCLUSION CRITERIA FOR NORMAL BRONCHOSCOPY SUBJECT:

Any healthy adult subject with no history of peripheral or coronary artery disease, who is eligible for bronchoalveolar lavage per Protocol 99-H-0068 and capable of giving informed consent.

EXCLUSION CRITERIA:

Unable to give consent

History of chronic infections, vasculitis or any other inflammatory disease

History of neoplastic disease or chemotherapy treatment

Immunosuppressive medications other than common over-the-counter drugs such as aspirin or acetaminophen

EXCLUSION CRITERIA FOR MEDICATION TREATED SUBJECT:

Subject with abnormal liver and renal function tests on pretreatment screening or currently taking a statin or ACE inhibitor medication.

EXCLUSION CRITERIA FOR NORMAL BRONCHOSCOPY SUBJECT:

Any exclusion criteria for normal subject listed in Protocol 99-H-0068.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To identify known and unknown genes involved in the pathogenesis of atherosclerosis for further analyses.
Tidsramme: ongoing
To identify known and unknown genes involved in the pathogenesis of atherosclerosis.
ongoing

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To identify atherosclerosis-specific genes expressed in peripheral monocytes, plaque macrophages or endothelial cells that may serve as early markers for disease diagnosis
Tidsramme: ongoing
To identify atherosclerosis-specific genes expressed in peripheral monocytes, plaque macrophages or endothelial cells that may serve as early markers for disease diagnosis
ongoing
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
Tidsramme: ongoing
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
ongoing

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

  • Hovedetterforsker: Paul M Hwang, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. oktober 2002

Primær fullføring (Faktiske)

16. mars 2005

Studiet fullført (Faktiske)

12. januar 2011

Datoer for studieregistrering

Først innsendt

18. juli 2006

Først innsendt som oppfylte QC-kriteriene

18. juli 2006

Først lagt ut (Anslag)

19. juli 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 020265
  • 02-H-0265

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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