Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients

NCT04960371 | Unknown

• 1 other identifier: M2018058
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Microvascular Disease; Anxiety State

Keywords

anxiety; coronary microcirculatory function; hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory mediators

  baseline

Study Arms (2)

anxiety group

the score of Self-rating Anxiety Scale greater than 50

Diagnostic Test: coronary flow reserve (CFR)

non-anxiety group

the score of Self-rating Anxiety Scale less than 50

Diagnostic Test: coronary flow reserve (CFR)

Interventions

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.

anxiety group; non-anxiety group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The serum sample

MeSH Terms

Conditions

Microvascular Angina; Anxiety Disorders; Hypertension

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mental Disorders

Study Officials

• Lijun Guo

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Lijun Guo

CONTACT

+8682265018; guo_li_jun@126.com

Ying Li

CONTACT

18811735238; liying_winter@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 13, 2021
• Study Start: June 28, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)