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The Effect of Autonomic Function on Coronary Vasomotion

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ClinicalTrials.gov Identifier: NCT01877993
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : August 27, 2013
Sponsor:
Collaborator:
Korea Institute of Science and Technology
Information provided by (Responsible Party):
Hong Seog Seo, Korea University

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.

Condition or disease
Coronary Artery Spasm Autonomic Dysfunction

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).

Study Type : Observational [Patient Registry]
Actual Enrollment : 2169 participants
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
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps
U.S. FDA Resources




Primary Outcome Measures :
  1. development of significant CAS [ Time Frame: during the Ach provocation test ]
    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 :
  1. Transient high-grade AV block [ Time Frame: occurred in response to Ach injection ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01877993     History of Changes
Other Study ID Numbers: BP-CAS
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013

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

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