Coronary Microvascular DiseaseNCT04960371
Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients
An observational study of Coronary Microvascular Disease and Anxiety State, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Microvascular Disease, Anxiety State
- What is being tested?
- coronary flow reserve (CFR)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2018to 30 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The hypertensive patients with chest pain for suspicious coronary heart disease (CHD) in Peking University Third Hospital were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of OCAD.
Who may be able to join
- Patients with clear diagnosis of hypertension (≥1 year, drug control within 140/90mmHg); (2) Significant coronary artery stenosis was excluded by imaging within 1 year (≤50%); (3) Age between 18 and 80.
Who cannot join
- CHD, heart valve disease, congenital heart disease, cardiomyopathy and pericardial disease; (2) Left ventricular ejection fraction (LVEF) <50%; (3) Increased markers of myocardial injury; (4) Diabetes mellitus, connective tissue disease, chronic obstructive pulmonary disease and malignant tumor; 5) Severe hepatic and renal impairment (Cr ≥120 umol/L, ALT ≥120 umol/L); 6) Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Ying Li, 18811735238, liying_winter@163.com
About this study
This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.
Read the detailed description
This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.The hypertensive patients with chest pain for suspicious coronary heart disease were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of obstructive coronary artery disease . Coronary flow reserve (CFR) is an integrated measure of flow through both the large epicardial arteries and the coronary microcirculation. In the absence of obstructive stenosis of the epicardial arteries, CFR is an indicator of coronary microcirculatory function，which can be assayed by Transthoracic Doppler echocardiography. The symptoms of anxiety were measured with Self-rating Anxiety Scale (SAS) . According to the SAS score,the patients were divided into anxiety group and non-anxiety group.We assessed the association of anxiety with coronary microcirculatory function.
- Conditions
- Coronary Microvascular Disease, Anxiety State
- Being tested
- coronary flow reserve (CFR)
- Keywords
- anxiety, coronary microcirculatory function, hypertension
- Medical subject headings
- Microvascular Angina, Anxiety Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary flow reserve (CFR)Diagnostic test
Coronary flow velocity profiles in the left anterior descending artery were obtained using colour-guided pulse wave Doppler. We measured peak diastolic coronary flow velocity of the diastolic coronary waveform at rest and after ATP infusion (140 µg/kg. min) for 2 min. The CFR was calculated as the ratio of hyperaemic peak diastolic velocity to resting baseline diastolic velocity. All patients abstained from caffeine-containing drinks for at least 24h before testing.
| Study group | Role | What they receive |
|---|---|---|
| anxiety group | the score of Self-rating Anxiety Scale greater than 50 Receives: Diagnostic Test: coronary flow reserve (CFR) | |
| non-anxiety group | the score of Self-rating Anxiety Scale less than 50 Receives: Diagnostic Test: coronary flow reserve (CFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow reserve
Coronary flow reserve (CFR) is an integrated measure of flow through both the large epicardial arteries and the coronary microcirculation. In the absence of obstructive stenosis of the epicardial arteries, CFR is an index of coronary microcirculatory function.
Measured: baseline
Secondary outcomes (1)
Inflammatory mediators
Inflammatory mediators were measured using Quantibody Human Immune Response Array.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start28 Jun 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lijun Guo, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960371
- Sponsor's protocol ID
- M2018058
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04960371
- Acronym / sponsor ID
- M2018058
- Conditions
- Coronary Microvascular Disease, Anxiety State
- Keywords
- anxiety, coronary microcirculatory function, hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Jul 2021 (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.
This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.
Detailed description
This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.The hypertensive patients with chest pain for suspicious coronary heart disease were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of obstructive coronary artery disease . Coronary flow reserve (CFR) is an integrated measure of flow through both the large epicardial arteries and the coronary microcirculation. In the absence of obstructive stenosis of the epicardial arteries, CFR is an indicator of coronary microcirculatory function，which can be assayed by Transthoracic Doppler echocardiography. The symptoms of anxiety were measured with Self-rating Anxiety Scale (SAS) . According to the SAS score,the patients were divided into anxiety group and non-anxiety group.We assessed the association of anxiety with coronary microcirculatory function.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anxiety group | – | Diagnostic Test: coronary flow reserve (CFR)the score of Self-rating Anxiety Scale greater than 50 |
| non-anxiety group | – | Diagnostic Test: coronary flow reserve (CFR)the score of Self-rating Anxiety Scale less than 50 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The hypertensive patients with chest pain for suspicious coronary heart disease (CHD) in Peking University Third Hospital were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of OCAD.
Key inclusion criteria (1 listed)
- Patients with clear diagnosis of hypertension (≥1 year, drug control within 140/90mmHg); (2) Significant coronary artery stenosis was excluded by imaging within 1 year (≤50%); (3) Age between 18 and 80.
Key exclusion criteria (1 listed)
- CHD, heart valve disease, congenital heart disease, cardiomyopathy and pericardial disease; (2) Left ventricular ejection fraction (LVEF) <50%; (3) Increased markers of myocardial injury; (4) Diabetes mellitus, connective tissue disease, chronic obstructive pulmonary disease and malignant tumor; 5) Severe hepatic and renal impairment (Cr ≥120 umol/L, ALT ≥120 umol/L); 6) Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary flow reserve (CFR)Coronary flow velocity profiles in the left anterior descending artery were obtained using colour-guided pulse wave Doppler. We measured peak diastolic coronary flow velocity of the diastolic coronary waveform at rest and after ATP infusion (140 µg/kg. min) for 2 min. The CFR was calculated as the ratio of hyperaemic peak diastolic velocity to resting baseline diastolic velocity. All patients abstained from caffeine-containing drinks for at least 24h before testing. | Diagnostic test | anxiety group, non-anxiety group |
Primary outcome
Coronary flow reserve
Time frame: baseline
Coronary flow reserve (CFR) is an integrated measure of flow through both the large epicardial arteries and the coronary microcirculation. In the absence of obstructive stenosis of the epicardial arteries, CFR is an index of coronary microcirculatory function.
1 secondary outcome
Inflammatory mediators
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- 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.
Lijun Guo study director
Peking University Third Hospital
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 Coronary Microvascular Disease and Anxiety State, run by Peking University Third 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 1 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 13 Jul 2021. 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 Lijun Guo (+8682265018, guo_li_jun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary flow reserve (time frame: baseline). 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 13 Jul 2021.