Clinical trial NCT01882790: The Prevalence of Coronary Spasm in Hypertensive Patients Treated With Antihypertensive Medication
Official title: The Association of Acetylcholine-induced Coronary Artery Spasm With the Blood Pressure Level in Hypertensive Patients Treated With Blood Pressure Lowering Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Spasm
Hypertension
Keywords: coronary artery spasm
hypertension
Pathophysiology
atrioventricular block
blood pressure
autonomic nervous function
Lead sponsor: Korea University
Sponsor class: OTHER
Collaborators: name: Korea Institute of Science and Technology
First posted: 2013-06-20
Enrollment: 1933
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 5,304 consecutive patients in the CAS registry of the Cardiovascular Center at Korea University Guro Hospital

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Development of significant CAS
timeFrame: baseline
Secondary outcomes:
measure: Transient high-grade AV block
timeFrame: baseline
Other outcomes:
measure: incidence of CAS in each antihypertensive agent.
timeFrame: : baseline
Locations:
city: Gunpo
country: Korea, Republic of
facility: Department of Internal Medicine, Division of Cardiology, Sanbon Hospital, Wonkwang University College of Medicine
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Cardiovascular Center, Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Institute of Science and Technology
Study officials:
References: