Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients

• Conditions: Anxiety State; Coronary Microvascular Disease
• Interventions: Diagnostic Test: coronary flow reserve (CFR)

• Registration Number: NCT04960371
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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 Timeline

• Study Start: 2018-06-28
• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-anxiety group	coronary flow reserve (CFR)	the score of Self-rating Anxiety Scale less than 50
anxiety group	coronary flow reserve (CFR)	the score of Self-rating Anxiety Scale greater than 50

Primary Outcome Measures

Name	Time	Method
Coronary flow reserve	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.

Secondary Outcome Measures

Name	Time	Method
Inflammatory mediators	baseline	Inflammatory mediators were measured using Quantibody Human Immune Response Array.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China