Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients

Anxiety State Clinical Trial

Official title:

Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960371
• Other study ID #: M2018058
• Status: Recruiting
• Start date: June 28, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Lijun Guo
• Phone: +8682265018
• Email: guo_li_jun[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Coronary Microvascular Disease
• Microvascular Angina

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Secondary	Inflammatory mediators	Inflammatory mediators were measured using Quantibody Human Immune Response Array.	baseline