- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01877993
The Effect of Autonomic Function on Coronary Vasomotion
August 23, 2013 updated by: Hong Seog Seo, Korea University
The Association of Acetylcholine-induced Coronary Artery Spasm With the Blood Pressure Level
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
2169
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 152-703
- Hong Seog Seo
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Seoul, Korea, Republic of
- Korea Institute of Science and Technology
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Gyeonggi-do
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Gunpo, Gyeonggi-do, Korea, Republic of
- Department of Internal Medicine, Division of Cardiology, Sanbon Hospital, Wonkwang University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
development of significant CAS
Time Frame: during the Ach provocation test
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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.
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during the Ach provocation test
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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occurred in response to Ach injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hong Seog Seo, MD, Ph., Korea University Guro Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
June 12, 2013
First Submitted That Met QC Criteria
June 13, 2013
First Posted (Estimate)
June 14, 2013
Study Record Updates
Last Update Posted (Estimate)
August 27, 2013
Last Update Submitted That Met QC Criteria
August 23, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-CAS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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