Angina Patients With Non-obstructive Coronary Artery DiseaseNCT06503640
Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease (ANOCA-CMD)
An observational study of Angina Patients With Non-obstructive Coronary Artery Disease and Coronary Microvascular Dysfunction, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction, Index of Microvascular Resistance
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Jingang Zheng, 01084205625, mdjingangzheng@yeah.net
About this study
Official title: Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE in 12 months
major adverse cardiovascular events 12 months, including cardiac death, myocardial infarction, and readmission for angina.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina Patients With Non-obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingang Zheng, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503640
- Sponsor's protocol ID
- 2023-KY-077
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06503640
- Acronym / sponsor ID
- 2023-KY-077
- Conditions
- Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction, Index of Microvascular Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE in 12 months
Time frame: 12 months
major adverse cardiovascular events 12 months, including cardiac death, myocardial infarction, and readmission for angina.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Patients With Non-obstructive Coronary Artery Disease and Coronary Microvascular Dysfunction, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoxue Sheng, Doctor (+86-15600268925, shengzhaoxue@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE in 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.