The Prevalence of Coronary Spasm in Hypertensive Patients Treated With Antihypertensive Medication

Hypertension Clinical Trial

Official title:

The Association of Acetylcholine-induced Coronary Artery Spasm With the Blood Pressure Level in Hypertensive Patients Treated With Blood Pressure Lowering Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882790
• Other study ID #: HTN-CAS
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: August 23, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Autonomic nerve function is involved in both blood pressure (BP) regulation and the pathogenesis of coronary artery spasm(CAS), but few studies have been published about the relationship between CAS and effect of BP lowering drugs in patients with hypertension. The purpose of this study is to investigate the incidence of CAS, atrioventricular (AV) block and effect of BP lowering drugs on CAS in hypertensive patients treated with BP lowering agents. The investigators will register consecutive patients who underwent coronary angiography with an acetylcholine (Ach)-induced provocation test. The investigators will include hypertensive patients who were taking antihypertensive drugs, and exclude patients who had a documented history of cardiovascular disease or who were not treated with antihypertensive agents. CAS is defined as >70% luminal narrowing on Ach provocation and /or concurrent chest pain. The study population will be divided into quartiles of rising systolic BP and diastolic BP. The incidence of Ach-induced CAS according to each systolic BP/diastolic BP quartile will be evaluated.

Description:

A total of consecutive patients in the CAS registry of the Cardiovascular Center at Korea University Guro Hospital and who had resting chest pain without significant coronary lesions (luminal narrowing <50%) underwent a provocation test with Ach infusion during coronary angiography from November 2004 to May 2012 will be reviewed. Among them, patients with documented cardiovascular disease and/or any other serious medical condition, such as an increased serum creatinine level (>2mg/dl), will be excluded. Patients will be excluded due to incomplete data. The investigators will register hypertensive patients who are currently using antihypertensive medications. The study population will be divided into quartiles based on rising systolic BP, diastolic BP, and pulse pressure. CAS+chest pain(CP) means>70% luminal narrowing on Ach provocation test. and/or concurrent typical chest pain.

BP was measured with a noninvasive BP monitoring device with the patient lying on the angiographic table after a five-minute rest (Patient monitoring system, NP 30:Philips, Amsterdam, The Netherlands). The first reading was discarded, and the mean of the next two consecutive readings was used. Next, coronary angiography was performed. Hypertension is defined as systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg on at least two consecutive readings in the outpatient clinic. Patients taking antihypertensive medications are also categorized as hypertensives. Other Risk factors for CAS examined in this study include hyperlipidemia (total cholesterol level ≥200mg /dl or current medication with lipid-lowering drugs), diabetes (fasting blood glucose≥126mg /dl, and/or glycated Hemoglobin A1c level more than 6.5% or current use of medications), current smoker (active smoking within the past 12 months), and current alcohol user (at least 1 alcohol drinking a week).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1933
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hypertensive patients who are treated with antihypertensive drugs have resting chest pain without significant coronary lesions(luminal narrowing <50%) underwent a provocation test with Ach infusion during coronary angiography.

Exclusion Criteria:

• Patients with documented cardiovascular disease and/or any other serious medical condition, such as an increased serum creatinine level(>2mg/dl), patients with incomplete data, or patients who were not treated with antihypertensive agents

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Spasm
• Coronary Vasospasm
• Hypertension
• Muscle Cramp
• Spasm

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Division of Cardiology, Sanbon Hospital, Wonkwang University College of Medicine	Gunpo	Gyeonggi-do
Korea, Republic of	Cardiovascular Center, Korea University Guro Hospital	Seoul
Korea, Republic of	Korea Institute of Science and Technology	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University	Korea Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of CAS in each antihypertensive agent.	comparison of CAS incidence in each antihypertensive agent	: baseline	No
Primary	Development of significant CAS	During the Ach provocation test, significant CAS was recorded when present, and investigators recorded whether is was associated with any of the following criteria: 1) >70% luminal narrowing on coronary angiography; 2) >70% luminal narrowing on coronary angiography and concurrent chest pain;3) >70% luminal narrowing on coronary angiography, concurrent chest pain and EKG changes(ST-segment elevation or depression =1mm); 4) >90% luminal narrowing induced by A3 dose on coronary angiography and concurrent chest pain.	baseline	No
Secondary	Transient high-grade AV block	Transient high-grade AV block that occurred in response to Ach injection is defined as such if it consisted of multiple sequential P waves that should conduct, but did not.	baseline	No