NCT00719992

Brief Summary

The aim of this study was to assess the amount of additive value of HS-CRP levels to a positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using coronary angiography as the gold standard. The investigators concluded that HS-CRP can be used as a single predictor of coronary vessel involvement in patients with stable angina and positive ETT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

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

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
Last Updated

July 22, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

July 18, 2008

Last Update Submit

July 18, 2008

Conditions

Stable AnginaPositive ETT

Keywords

Exercise tolerance testHS-CRPCoronary angiographyPatients

Outcome Measures

Primary Outcomes (1)

  • significant coronary lesion

Secondary Outcomes (1)

  • severity of CAD

Study Arms (2)

1

EXPERIMENTAL

positive ETT, High HS-CRP

Procedure: coronary angiography

2

ACTIVE COMPARATOR

positive ETT, Low HS-CRP

Procedure: coronary angiography

Interventions

coronary angiographyPROCEDURE

effect of level of HS-CRP

12

Eligibility Criteria

Age43 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Stable angina
  • Positive ETT

You may not qualify if:

  • Unability to perform ETT
  • Contraindications for ETT and angiography study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Ward Shiraz University of Medical Sciences

Shiraz, Fars, 51318, Iran

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

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

Study Officials

  • javad kojuri, M.D.

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

April 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

July 22, 2008

Record last verified: 2008-07

Locations

IR(1)