- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01645228
Could Non-invasive Biochemical, Image or Physiological Index Predict Significant Coronary Arterial Stenosis in Symptomatic Adults?
August 14, 2012 updated by: Cathay General Hospital
To validate the capability of non-invasive bio-image tests in prediction of significant coronary stenosis of symptomatic adults.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuan Heng Mo, MD
- Phone Number: 8181 886-2-27082121
- Email: jamesmyh@yahoo.com.tw
Study Locations
-
-
-
Taipei, Taiwan, 106
- Recruiting
- Cathay General Hospital
-
Principal Investigator:
- Yuan Heng Mo, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
population for a general health check-up
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
significant coronary artery stenosis
anyone coronary segment > 50% diameter stenosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
coronary CT angiography
Time Frame: within one month
|
within one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yuan Heng Mo, MD. PhD, Cathay General Hospital, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
July 18, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
August 16, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGH-P100133
- NSC 101-2314-B-281 -007 (Other Grant/Funding Number: National Science Council, Taiwan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Heart Disease
-
Peking University Third HospitalCompletedCoronary Microvascular Dysfunction | Obstructive Coronary Heart DiseaseChina
-
Shenyang Northern HospitalNot yet recruitingCoronary Heart Disease (CHD)China
-
Johns Hopkins UniversityCanon Medical Systems, USARecruiting
-
MedImmune LLCCompletedStable Coronary Heart DiseaseUnited States
-
Medical University of LodzBaxter Healthcare CorporationUnknownCHD - Coronary Heart DiseasePoland
-
University of ZurichCompletedStable Coronary Heart DiseaseSwitzerland
-
Hamad Medical CorporationMayo ClinicCompleted
-
Centro de estudios en Cardiologia IntervencionistaCompletedCoronary Heart Disease | Coronary RestenosisArgentina
-
Deutsches Herzzentrum MuenchenCompletedCoronary Heart DiseaseGermany
-
Henan Institute of Cardiovascular EpidemiologyNot yet recruitingStable Coronary Heart Disease
Clinical Trials on coronary calcium score measurement
-
Montefiore Medical CenterWithdrawnChest PainUnited States
-
Baker Heart and Diabetes InstituteRecruitingCoronary Artery DiseaseAustralia
-
Shiraz University of Medical SciencesCompletedCoronary Artery DiseaseIran, Islamic Republic of
-
CHU de ReimsRecruitingOut of Hospital Cardiac Arrest Without ST-segment ElevationFrance
-
St. Joseph's Hospital and Medical Center, PhoenixChandler Regional Medical Center; Mercy Gilbert Medical CenterRecruitingCoronary Artery Disease | Genetic Predisposition to DiseaseUnited States
-
University of LeedsBritish Heart Foundation; University of Leicester; University of GlasgowCompletedCoronary Heart DiseaseUnited Kingdom
-
Aseer Central HospitalArmed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM); King Khalid...CompletedSepsis | Septic ShockQatar, United Arab Emirates, Turkey, Bahrain, Kuwait, Oman, Saudi Arabia
-
French Cardiology SocietyNovo Nordisk A/S; CEBIMERNot yet recruitingCardiovascular Diseases | Diabetes MellitusFrance
-
University of EdinburghNHS Lothian; British Heart FoundationRecruitingCardiovascular DiseasesUnited Kingdom
-
Stanford UniversityCompleted