Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety State; Coronary Microvascular Disease
• Intervention / Treatment: Diagnostic test: coronary flow reserve (CFR)

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Lijun Guo; Phone Number: +8682265018; Email: guo_li_jun@126.com
• Study Contact Backup: Name: Ying Li; Phone Number: 18811735238; Email: liying_winter@163.com

Study Locations

• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
    • Contact: Ying Li; Phone Number: 18811735238; Email: liying_winter@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
anxiety group; the score of Self-rating Anxiety Scale greater than 50	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.
non-anxiety group; the score of Self-rating Anxiety Scale less than 50	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory mediators	Inflammatory mediators were measured using Quantibody Human Immune Response Array.	baseline

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Lijun Guo, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: hypertension; anxiety; coronary microcirculatory function
• Additional Relevant MeSH Terms: Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Anxiety Disorders; Microvascular Angina
• Other Study ID Numbers: M2018058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No