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

NCT01882790 | Completed

• 1 other identifier: HTN-CAS
• Study Type: observational
• Target: 1,933
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Spasm; Hypertension

Keywords

coronary artery spasm; hypertension; Pathophysiology; atrioventricular block; blood pressure; autonomic nervous function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Transient high-grade AV block

  baseline

Other Outcomes (1)

• incidence of CAS in each antihypertensive agent.

  : baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University: lead
• Korea Institute of Science and Technology: collaborator

Study Sites (3)

Department of Internal Medicine, Division of Cardiology, Sanbon Hospital, Wonkwang University College of Medicine

Gunpo, Gyeonggi-do, South Korea

Location

Cardiovascular Center, Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Korea Institute of Science and Technology

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Vasospasm; Hypertension; Atrioventricular Block

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 20, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

KR (3)