NCT02179047

Brief Summary

Through the literature review , we pick out a series of forward-looking biological indicators as follows :

  1. 1.NGAL
  2. 2.Cystatin C:
  3. 3.Galectin-3:
  4. 4.Copeptin:
  5. 5.MR-Pro ANP:
  6. 6.sST2:

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

May 27, 2014

Results QC Date

November 10, 2017

Last Update Submit

February 21, 2020

Conditions

Keywords

SYNTAX ,NGAL,Cystatin C,Galectin-3,Copeptin.MR-ProANP,sST2.

Outcome Measures

Primary Outcomes (3)

  • Biomarker Titer of Patients With Coronary Artery Disease

    The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).

    6-12 months

  • Biomarker of Healthy Subjects(Placebo)

    The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) of healthy subjects(placebo).

    6-12 months

  • SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram

    The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) with SYNTAX score. The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score. Low risk:\<22; intermediate risk: 22-33, high risk:\>33

    6-12 months

Study Arms (2)

stable angina, biomarker

patients with stable angina who received coronary angiography.

Procedure: coronary angiography

placebo

healthy subject

Procedure: coronary angiography

Interventions

percutaneous coronary intervention. coronary angiography.

placebostable angina, biomarker

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with stable angina who received coronary angiography.

You may qualify if:

  • stable angina who eligible for coronary angiography after non-invasive stress test.

You may not qualify if:

  • intolerance to procedure or contarst medium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ELISA kit for Human Galectin-3 Quantikine ELISA Kit (R\&D system, Minneapolis, Mn)、Human ST2/IL-1 R4 Quantikine ELISA Kit(R\&D system, Minneapolis, Mn)、Human Cystatin C Quantikine ELISA Kit(R\&D system, Minneapolis, Mn)、 Human Lipocalin-2/NGAL Quantikine ELISA Kit(R\&D system, Minneapolis, Mn)、Human midregional pro-atrial natriuretic peptide(MR-proANP) ELISA Kit(Cusabio, China, Cn)、Soluble ST2/IL-1R4 (HUMAN) Elisa Kit(AvisceraBioscience, Santa Clara,Ca)

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
chen yueh-chung
Organization
taipei city hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of ICU

Study Record Dates

First Submitted

May 27, 2014

First Posted

July 1, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

February 25, 2020

Results First Posted

February 25, 2020

Record last verified: 2017-04

Locations