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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01645228
• Other study ID #: CGH-P100133
• Secondary ID: NSC 101-2314-B-2
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2012
• Last updated: August 14, 2012
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2012
• Source: Cathay General Hospital
• Contact: Yuan Heng Mo, MD
• Phone: 886-2-27082121
• Email: jamesmyh[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Radiation:
• coronary calcium score measurement

Biological:
• high sensitivity C reactive protein measurement

Procedure:
• ankle brachial index measurement

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Cathay General Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coronary CT angiography		within one month	No