Clinical trial NCT01645228: Could Non-invasive Biochemical, Image or Physiological Index Predict Significant Coronary Arterial Stenosis in Symptomatic Adults?
Official title: Could Non-invasive Biochemical, Image or Physiological Index Predict Significant Coronary Arterial Stenosis in Symptomatic Adults?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population for a general health check-up

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: coronary CT angiography
timeFrame: within one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: Cathay General Hospital, Taiwan
name: Yuan Heng Mo, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.