NCT06503640

Brief Summary

The goal of this observational study is to explore the incidence and effect on prognosis of coronary microvascular dysfunction in patients present of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 10, 2024

Last Update Submit

July 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • MACE in 12 months

    major adverse cardiovascular events 12 months, including cardiac death, myocardial infarction, and readmission for angina.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients present of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80

You may qualify if:

  • presence of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80

You may not qualify if:

  • acute myocardial infarction
  • significant valvular heart disease
  • advanced chronic kidney disease
  • patients with significant epicardial coronary artery stenosis (\>70% in major vessels by diagnostic coronary angiography) needing percutaneous coronary intervention
  • patients unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Zhaoxue Sheng, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology Department

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

July 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations