NCT01176357

Brief Summary

Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening of the arteries, or atherosclerosis that is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees. Epidemiological studies have found that increased cardiovascular risks are associated with increased levels of inflammatory cytokines (eg, interleukin-6 \[IL-6\] and tumor necrosis factor-alpha\[TNF-alpha\]) or their hepatic product, C-reactive protein (CRP). Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic protein-1 (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients with CAD. These findings suggested that the pericoronary tissues could be a source of inflammatory mediators or act as paracrine that lead to vascular inflammation on CAD pathogenesis. However, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose tissue, has been reported to have a variety of anti-inflammatory functions against atherosclerosis, resulting in risk reduction for incidence of CAD events. It remains unclear whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to CAD. We therefore aim to analyze the expression of adiponectin and inflammatory mediators in mediastinal adipose tissue between patients with CAD and with valve diseases, and to correlate these parameters with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
Last Updated

August 6, 2010

Status Verified

August 1, 2010

Enrollment Period

11 months

First QC Date

February 6, 2009

Last Update Submit

August 4, 2010

Conditions

Keywords

Coronary artery disease (CAD)atherosclerosismediastinal adipose tissueadiponectin, inflammatory mediators

Study Arms (2)

1

CABG

2

Valve surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with CAD or with valve diseases proposed to have cardiac operations

You may qualify if:

  • patient underwent CABG or valve surgery in our hospital will be included

You may not qualify if:

  • liver disease
  • dhronic renal insufficiency
  • neoplastic diseases
  • taking steroids
  • congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FEMH

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Adipose tissue biopsy samples from mediastinal fat, epicardial fat, subcutaneous fat in thoracic region or abdominal region and subcutaneous fat in leg were obtained soon after sternotomy or thoracotomy before the initiation of cardiopulmonary bypass.

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kuan-Ming Chiu, MD, PhD

    FEMH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuan-Ming Chiu, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2009

First Posted

August 6, 2010

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Last Updated

August 6, 2010

Record last verified: 2010-08

Locations