The Effect of Autonomic Function on Coronary Vasomotion

This study has been completed.
Sponsor:
Collaborator:
Korea Institute of Science and Technology
Information provided by (Responsible Party):
Hong Seog Seo, Korea University
ClinicalTrials.gov Identifier:
NCT01877993
First received: June 12, 2013
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition
Coronary Artery Spasm
Autonomic Dysfunction

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: The Association of Acetylcholine-induced Coronary Artery Spasm With the Blood Pressure Level

Further study details as provided by Korea University:

Primary Outcome Measures:
  • development of significant CAS [ Time Frame: during the Ach provocation test ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Transient high-grade AV block [ Time Frame: occurred in response to Ach injection ] [ Designated as safety issue: No ]
    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.


Enrollment: 2169
Study Start Date: May 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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 registerd. 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 study population will be divided into quartiles based on rising systolic BP, diastolic BP, and pulse pressure. Each group will be defined as following criteria: 1) group 1: systolic BP <117mmHg, diastolic BP <69mmHg, and pulse pressure <42mmHg; 2) group 2: systolic BP 117-130 mmHg, diastolic BP 69-77 mmHg, and pulse pressure 42-51mmHg; 3) group 3: systolic BP 131-141 mmHg, diastolic BP 78-86 mmHg, and pulse pressure 52-61mmHg; and 4) group 4: systolic BP >141 mmHg, diastolic BP >86 mmHg, and pulse pressure >61mmHg. CAS+Chest Pain 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • patients had 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, and patients who had been diagnosed with hypertension or were currently using antihypertensive medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877993

Locations
Korea, Republic of
Department of Internal Medicine, Division of Cardiology, Sanbon Hospital, Wonkwang University
Gunpo, Gyeonggi-do, Korea, Republic of
Hong Seog Seo
Seoul, Korea, Republic of, 152-703
Korea Institute of Science and Technology
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University
Korea Institute of Science and Technology
Investigators
Principal Investigator: Hong Seog Seo, MD, Ph. Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01877993     History of Changes
Other Study ID Numbers: BP-CAS
Study First Received: June 12, 2013
Last Updated: August 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Korea University:
coronary artery spasm
pathophysiology
atrioventricular block
blood pressure
autonomic nervous function

Additional relevant MeSH terms:
Coronary Vasospasm
Spasm
Peripheral Vascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014