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AzTrials

Heart SurgeryNCT02519257

The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory Mediators With Cardiac Diseases

A study testing CAD and VHD in people with Heart Surgery, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Completed

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

Official record
Search all trials

Trial summary

Atherosclerosis is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees and is known as the main cause of coronary artery disease (CAD). Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Surgery
What is being tested?
CAD and VHD
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteTaiwan
Study dates
Aug 2008to Jul 2010
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • coronary artery bypass grafting surgery
  • valvular surgery

Who cannot join

  • liver disease (GPT 2 times greater than normal limits)
  • chronic renal insufficiency (Creatinine > 2.0 mg/dL)
  • neoplastic diseases
  • taking steroids
  • congestive heart failure

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Far Eastern Memorial Hospital

    New Taipei City, 220

Other trials in Taiwan

About this study

Official title: The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory

Atherosclerosis is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees and is known as the main cause of coronary artery disease (CAD). Recently, there are more and more studies highlighted the potential importance of adipose tissue in relation to inflammation effects on CAD pathogenesis. However, it remains unclear whether Thy-1, adiponectin or any other inflammatory mediators in mediastinal adipose tissue contribute to CAD. In this study, we aim to analyze the expression of inflammatory mediators' expression via in vitro assay (3T3-L1 cell culture) and in vivo assay (human adipose tissues).

Read the detailed description

In addition, we'd like to investigate the association of the investigators' findings with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar. Now, we've established cell assay and successfully transformed mature adipocyte from 3T3-L1 cells. Besides, there were nighty-six patients enrolled into this study. Flow cytometry of Thy-1 and MCP-1 concentration in cultured medium by ELISA were also analyzed.

Conditions
Heart Surgery
Being tested
CAD, VHD
Keywords
CAD, VHD, Thy-1

What participants receive

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

  • CADProcedure or surgery

    Also called coronary artery disease

    Patients with CAD diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.

  • VHDProcedure or surgery

    Also called valve diseases

    Patients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.

Study groups in NCT02519257
Study groupRoleWhat they receive
CADExperimentalPatients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.
Receives: Procedure: CAD
VHDExperimentalPatients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.
Receives: Procedure: VHD

What is being measured

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

  1. CD91 (Thy-1)

    Measured: up to 24 months

Secondary outcomes (1)

  1. CD45

    Measured: up to 24 months

Timeline

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

  1. First posted10 Aug 2015 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02519257
Sponsor's protocol ID
FEMH-96091
Status last verified
Aug 2015
First submitted
2 Aug 2015
Last updated
10 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Lindahl B, Toss H, Siegbahn A, Venge P, Wallentin L. Markers of myocardial damage and inflammation in relation to long-term mortality in unstable coronary artery disease. FRISC Study Group. Fragmin during Instability in Coronary Artery Disease. N Engl J Med. 2000 Oct 19;343(16):1139-47. doi: 10.1056/NEJM200010193431602.

    PubMed 11036119

  • Ridker PM, Rifai N, Stampfer MJ, Hennekens CH. Plasma concentration of interleukin-6 and the risk of future myocardial infarction among apparently healthy men. Circulation. 2000 Apr 18;101(15):1767-72. doi: 10.1161/01.cir.101.15.1767.

    PubMed 10769275

  • Ridker PM, Rifai N, Pfeffer M, Sacks F, Lepage S, Braunwald E. Elevation of tumor necrosis factor-alpha and increased risk of recurrent coronary events after myocardial infarction. Circulation. 2000 May 9;101(18):2149-53. doi: 10.1161/01.cir.101.18.2149.

    PubMed 10801754

  • Shimokawa H, Ito A, Fukumoto Y, Kadokami T, Nakaike R, Sakata M, Takayanagi T, Egashira K, Takeshita A. Chronic treatment with interleukin-1 beta induces coronary intimal lesions and vasospastic responses in pigs in vivo. The role of platelet-derived growth factor. J Clin Invest. 1996 Feb 1;97(3):769-76. doi: 10.1172/JCI118476.

    PubMed 8609234

  • Miyata K, Shimokawa H, Kandabashi T, Higo T, Morishige K, Eto Y, Egashira K, Kaibuchi K, Takeshita A. Rho-kinase is involved in macrophage-mediated formation of coronary vascular lesions in pigs in vivo. Arterioscler Thromb Vasc Biol. 2000 Nov;20(11):2351-8. doi: 10.1161/01.atv.20.11.2351.

    PubMed 11073837

  • Mazurek T, Zhang L, Zalewski A, Mannion JD, Diehl JT, Arafat H, Sarov-Blat L, O'Brien S, Keiper EA, Johnson AG, Martin J, Goldstein BJ, Shi Y. Human epicardial adipose tissue is a source of inflammatory mediators. Circulation. 2003 Nov 18;108(20):2460-6. doi: 10.1161/01.CIR.0000099542.57313.C5. Epub 2003 Oct 27.

    PubMed 14581396

  • Prescott MF, McBride CK, Court M. Development of intimal lesions after leukocyte migration into the vascular wall. Am J Pathol. 1989 Nov;135(5):835-46.

    PubMed 2817082

  • Ouchi N, Kihara S, Arita Y, Maeda K, Kuriyama H, Okamoto Y, Hotta K, Nishida M, Takahashi M, Nakamura T, Yamashita S, Funahashi T, Matsuzawa Y. Novel modulator for endothelial adhesion molecules: adipocyte-derived plasma protein adiponectin. Circulation. 1999 Dec 21-28;100(25):2473-6. doi: 10.1161/01.cir.100.25.2473.

    PubMed 10604883

  • Staiger H, Tschritter O, Machann J, Thamer C, Fritsche A, Maerker E, Schick F, Haring HU, Stumvoll M. Relationship of serum adiponectin and leptin concentrations with body fat distribution in humans. Obes Res. 2003 Mar;11(3):368-72. doi: 10.1038/oby.2003.48.

    PubMed 12634431

  • Yatagai T, Nagasaka S, Taniguchi A, Fukushima M, Nakamura T, Kuroe A, Nakai Y, Ishibashi S. Hypoadiponectinemia is associated with visceral fat accumulation and insulin resistance in Japanese men with type 2 diabetes mellitus. Metabolism. 2003 Oct;52(10):1274-8. doi: 10.1016/s0026-0495(03)00195-1.

    PubMed 14564678

  • Matsuzawa Y. Adipocytokines and metabolic syndrome. Semin Vasc Med. 2005 Feb;5(1):34-9. doi: 10.1055/s-2005-871744.

    PubMed 15968578

  • Filippi E, Sentinelli F, Romeo S, Arca M, Berni A, Tiberti C, Verrienti A, Fanelli M, Fallarino M, Sorropago G, Baroni MG. The adiponectin gene SNP+276G>T associates with early-onset coronary artery disease and with lower levels of adiponectin in younger coronary artery disease patients (age <or=50 years). J Mol Med (Berl). 2005 Sep;83(9):711-9. doi: 10.1007/s00109-005-0667-z. Epub 2005 May 5.

    PubMed 15877215

  • Shimabukuro M, Higa N, Asahi T, Oshiro Y, Takasu N, Tagawa T, Ueda S, Shimomura I, Funahashi T, Matsuzawa Y. Hypoadiponectinemia is closely linked to endothelial dysfunction in man. J Clin Endocrinol Metab. 2003 Jul;88(7):3236-40. doi: 10.1210/jc.2002-021883.

    PubMed 12843170

  • Fernandez-Real JM, Lopez-Bermejo A, Casamitjana R, Ricart W. Novel interactions of adiponectin with the endocrine system and inflammatory parameters. J Clin Endocrinol Metab. 2003 Jun;88(6):2714-8. doi: 10.1210/jc.2002-021583.

    PubMed 12788878

  • Yokota T, Oritani K, Takahashi I, Ishikawa J, Matsuyama A, Ouchi N, Kihara S, Funahashi T, Tenner AJ, Tomiyama Y, Matsuzawa Y. Adiponectin, a new member of the family of soluble defense collagens, negatively regulates the growth of myelomonocytic progenitors and the functions of macrophages. Blood. 2000 Sep 1;96(5):1723-32.

    PubMed 10961870

Questions about this trial

What is this clinical trial studying?

A study testing CAD and VHD in people with Heart Surgery, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

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 2 inclusion and 5 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 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

CD91 (Thy-1) (time frame: up to 24 months). 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 NCT02519257, which also lists 25 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 10 Aug 2015.

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