NCT02310659

Brief Summary

Coronary artery calcification (CAC) is a pandemic condition in elderly patients with coronary artery disease (CAD) and associated with worse prognosis. Although available data shows association between testosterone levels in men and CAD, the association between testosterone and CAC in old-aged male patients with CAD remains unknown. In this study, the relationship of serum testosterone levels with CAC score in elderly male patients with CAD was evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

6 years

First QC Date

December 1, 2014

Last Update Submit

December 3, 2014

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Number of participants with severe coronary artery calcification

    Number of participants with coronary artery calcification score ≥400

    10 months

Study Arms (2)

lower calcificant score group

patients with coronary artery calcificant score \<400

Other: No intervention

higher calcificant score group

patients with coronary artery calcificant score ≥400

Other: No intervention

Interventions

No interventionOTHER

No intervention

higher calcificant score grouplower calcificant score group

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly male patients (age ≥ 65 years old) with stable angina and proven coronary artery disease

You may qualify if:

  • Elderly male patients (age ≥ 65 years old) with stable angina and proven coronary artery disease

You may not qualify if:

  • Less than 65 years old
  • Acute coronary syndrome
  • History of PCI or coronary artery bypass grafting
  • History of myocardial infarction
  • Renal dysfunction defined by glomerular filtration rate \< 30 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Junzhu Chen, MD

    Zhejiang University

    STUDY CHAIR

Central Study Contacts

Jiangtao Lai, MD

CONTACT

+8657187236502

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 8, 2014

Study Start

March 1, 2009

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

CN(1)