Could Non-invasive Biochemical, Image or Physiological Index Predict Significant Coronary Arterial Stenosis in Symptomatic Adults?

NCT ID: NCT01645228

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-07-31

Brief Summary

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To validate the capability of non-invasive bio-image tests in prediction of significant coronary stenosis of symptomatic adults.

Detailed Description

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The main objective is to validate the capability of these non-invasive tests (CCS, hs-CRP and ABI) in prediction of significant coronary stenosis of symptomatic adults. The end-point will be the findings of coronary CT angiography. The investigators hope the results of our study could be applied on the interpretation of health examination and the advice of follow-up and therapy.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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significant coronary artery stenosis

anyone coronary segment \> 50% diameter stenosis

coronary calcium score measurement

Intervention Type RADIATION

high sensitivity C reactive protein measurement

Intervention Type BIOLOGICAL

ankle brachial index measurement

Intervention Type PROCEDURE

Interventions

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coronary calcium score measurement

Intervention Type RADIATION

high sensitivity C reactive protein measurement

Intervention Type BIOLOGICAL

ankle brachial index measurement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* subjects for a general health check-up protocol, which included CACS and CCTA, and biochemical measurements (total cholesterol, total triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, high sensitivity C reactive protein)

Exclusion Criteria

* anyone allergy to iodine contrast medium, unable cooperation for CT scanning, asymptomatic
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Cathay General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuan Heng Mo, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Cathay General Hospital, Taiwan

Locations

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Cathay General Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yuan Heng Mo, MD

Role: CONTACT

Phone: 886-2-27082121

Email: [email protected]

References

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Muntendam P, McCall C, Sanz J, Falk E, Fuster V; High-Risk Plaque Initiative. The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. Am Heart J. 2010 Jul;160(1):49-57.e1. doi: 10.1016/j.ahj.2010.02.021.

Reference Type BACKGROUND
PMID: 20598972 (View on PubMed)

Greenland P, Alpert JS, Beller GA, Benjamin EJ, Budoff MJ, Fayad ZA, Foster E, Hlatky MA, Hodgson JM, Kushner FG, Lauer MS, Shaw LJ, Smith SC Jr, Taylor AJ, Weintraub WS, Wenger NK, Jacobs AK, Smith SC Jr, Anderson JL, Albert N, Buller CE, Creager MA, Ettinger SM, Guyton RA, Halperin JL, Hochman JS, Kushner FG, Nishimura R, Ohman EM, Page RL, Stevenson WG, Tarkington LG, Yancy CW; American College of Cardiology Foundation; American Heart Association. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010 Dec 14;56(25):e50-103. doi: 10.1016/j.jacc.2010.09.001. No abstract available.

Reference Type BACKGROUND
PMID: 21144964 (View on PubMed)

Lim LS, Haq N, Mahmood S, Hoeksema L; ACPM Prevention Practice Committee; American College of Preventive Medicine. Atherosclerotic cardiovascular disease screening in adults: American College Of Preventive Medicine position statement on preventive practice. Am J Prev Med. 2011 Mar;40(3):381.e1-10. doi: 10.1016/j.amepre.2010.11.021.

Reference Type BACKGROUND
PMID: 21335273 (View on PubMed)

Blaha MJ, Budoff MJ, DeFilippis AP, Blankstein R, Rivera JJ, Agatston A, O'Leary DH, Lima J, Blumenthal RS, Nasir K. Associations between C-reactive protein, coronary artery calcium, and cardiovascular events: implications for the JUPITER population from MESA, a population-based cohort study. Lancet. 2011 Aug 20;378(9792):684-92. doi: 10.1016/S0140-6736(11)60784-8.

Reference Type BACKGROUND
PMID: 21856482 (View on PubMed)

Ridker PM. High-sensitivity C-reactive protein, vascular imaging, and vulnerable plaque: more evidence to support trials of antiinflammatory therapy for cardiovascular risk reduction. Circ Cardiovasc Imaging. 2011 May;4(3):195-7. doi: 10.1161/CIRCIMAGING.111.965053. No abstract available.

Reference Type BACKGROUND
PMID: 21586741 (View on PubMed)

Murphy TP, Dhangana R, Pencina MJ, D'Agostino RB Sr. Ankle-brachial index and cardiovascular risk prediction: an analysis of 11,594 individuals with 10-year follow-up. Atherosclerosis. 2012 Jan;220(1):160-7. doi: 10.1016/j.atherosclerosis.2011.10.037. Epub 2011 Nov 3.

Reference Type BACKGROUND
PMID: 22099055 (View on PubMed)

Other Identifiers

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NSC 101-2314-B-281 -007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CGH-P100133

Identifier Type: -

Identifier Source: org_study_id