The Effect of Autonomic Function on Coronary Vasomotion

NCT01877993 | Completed

• 1 other identifier: BP-CAS
• Study Type: observational
• Target: 2,169
• 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 BP, with the exception of studies that explore hypertension as a risk factor for CAS. The purpose of this study was to investigate the incidence of CAS and atrioventricular (AV) block in association with BP level. The investigators will register consecutive patients who underwent coronary angiography with an acetylcholine (Ach)-induced provocation test from November 2004 to May 2012. The investigators exclude from the patients who were taking antihypertensive drugs or who had a documented history of cardiovascular disease in order to avoid the confounding effects of cardiovascular medications on coronary vasomotion. 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; Autonomic Dysfunction

Keywords

coronary artery spasm; 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 we recorded whether it was associated with any of the four following criteria: 1) chest pain only during Ach provocation test 2) \>70% luminal narrowing on coronary angiography and concurrent typical chest pain;3) \>70% luminal narrowing on coronary angiography and/or concurrent chest pain and EKG changes(ST-segment elevation or depression ≥1mm); 4) \>90% luminal narrowing induced by A3 dose on coronary angiography and/or concurrent chest pain.

  during the Ach provocation test

Secondary Outcomes (1)

• Transient high-grade AV block

  occurred in response to Ach injection

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:

• patients had 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, and patients who had been diagnosed with hypertension or were currently using antihypertensive medications.

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

Gunpo, Gyeonggi-do, South Korea

Location

Hong Seog Seo

Seoul, 152-703, South Korea

Location

Korea Institute of Science and Technology

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Vasospasm; Primary Dysautonomias; Atrioventricular Block

Condition Hierarchy (Ancestors)

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

Study Officials

• Hong Seog Seo, MD, Ph.

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• 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 12, 2013
• First Posted: June 14, 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)