CClinicalTrials.gg
CompletedNCT00737945Updated Aug 24, 2017

Prognostic Value of Endothelial Dysfunction and Coronary Complexity

An observational study in Cardiovascular Disease, sponsored by Kumamoto University. Completed at 1 site in Japan. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Kumamoto University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
30 Years to 90 Years
Sex
All
01

Study summary

The investigators test the additional clinical value of the physiological assessment of endothelial function to the morphological assessment of coronary complexity and classical risk score in predicting cardiovascular events.

Read the detailed description

The investigators enroll consecutive, stable high risk patients for cardiovascular events. The reactive hyperemia peripheral arterial tonometry index (RHI) was measured before coronary angiography and coronary lesions were assessed angiographically by SYNTAX Scoring system. The investigators all subjects and examined the occurrence of cardiovascular events (CV death, non-fatal myocardial infarction and ischemic stroke, unstable angina pectoris, hospitalization for HF, coronary revascularization, or non-fatal aortic and peripheral vascular disease).

02

Conditions studied

  • Cardiovascular Disease
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 1,000 is above the median of 573 across 1,483 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Kumamoto University is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Kumamoto University Hospital and Yokohama City University Medical Center

Inclusion criteria

  • Stable, high-risk patients with diabetes mellitus, or more than two conventional coronary risk factors, who are referred for coronary angiography because of angina-like chest symptoms.

Exclusion criteria

Exclusion Criteria:

  • An ejection fraction \< 50%
  • Moderate to severe valvular heart disease
  • Cardiomyopathy
  • Allergy to latex
  • Significant endocrine, hepatic, renal, or inflammatory disease
  • cerebrovascular disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 2
06

What researchers measure

Primary outcomes

  1. Cardiovascular event

    Cardiovascular event consists of cardiovascular death, myocardial infarction, unstable angina, ischemic stroke, coronary revascularization, hospitalization for heart failure, aortic disease and peripheral arterial disease.

    Time frame: Outcome is assessed 1 to 4 years after entry

07

Study locations

1 site
  • Kumamoto University Hospital
    Kumamoto, 860-8556, Japan
08

References and documents

Publications

  • Matsuzawa Y, Sugiyama S, Sumida H, Sugamura K, Nozaki T, Ohba K, Matsubara J, Kurokawa H, Fujisue K, Konishi M, Akiyama E, Suzuki H, Nagayoshi Y, Yamamuro M, Sakamoto K, Iwashita S, Jinnouchi H, Taguri M, Morita S, Matsui K, Kimura K, Umemura S, Ogawa H. Peripheral endothelial function and cardiovascular events in high-risk patients. J Am Heart Assoc. 2013 Nov 25;2(6):e000426. doi: 10.1161/JAHA.113.000426. PubMed 24275629 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00737945
Lead sponsor
Kumamoto University
Responsible party
Seigo Sugiyama (Department of Cardiovascular Medicine, Kumamoto University) — Principal investigator
First posted
Aug 20, 2008
Start date
Aug 2006
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Aug 24, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion