NCT00619294

Brief Summary

Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip RH-PAT could predict the presence of CSA in women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

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

Study Start

First participant enrolled

August 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

2.8 years

First QC Date

February 8, 2008

Last Update Submit

September 25, 2013

Conditions

Coronary Vasospasm

Keywords

Coronary VasospasmEndothelium, VascularVasodilationHyperemia

Outcome Measures

Primary Outcomes (1)

  • Ischemic heart disease diagnosed by cardiac catheterization

    From Aug 2006 to May 2009

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kumamoto University Hospital

You may qualify if:

  • Stable post-menopausal women complaining angina-like chest pain

You may not qualify if:

  • Severe valvular disease
  • Hypertrophic cardiomyopathy
  • Severe peripheral artery disease
  • Uncontrolled hypertension
  • Severe collagen diseases
  • Acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Related Publications (1)

  • Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, Matsubara J, Sumida H, Kaikita K, Kojima S, Nagayoshi Y, Yamamuro M, Izumiya Y, Iwashita S, Matsui K, Jinnouchi H, Kimura K, Umemura S, Ogawa H. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010 Apr 20;55(16):1688-96. doi: 10.1016/j.jacc.2009.10.073.

    PMID: 20394872DERIVED

MeSH Terms

Conditions

Coronary VasospasmAneurysmHyperemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 20, 2008

Study Start

August 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

JP(1)