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

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:
NCT01882790
First received: June 14, 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 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.


Condition
Coronary Artery Spasm
Hypertension

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
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 in Hypertensive Patients Treated With Blood Pressure Lowering Drugs

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Development of significant CAS [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Transient high-grade AV block [ Time Frame: baseline ] [ 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.


Other Outcome Measures:
  • incidence of CAS in each antihypertensive agent. [ Time Frame: : baseline ] [ Designated as safety issue: No ]
    comparison of CAS incidence in each antihypertensive agent


Enrollment: 1933
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 reviewed. 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 investigators will register hypertensive patients who are currently using antihypertensive medications. The study population will be divided into quartiles based on rising systolic BP, diastolic BP, and pulse pressure. CAS+chest pain(CP) 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:

  • 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.

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, or patients who were not treated with antihypertensive agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882790

Locations
Korea, Republic of
Department of Internal Medicine, Division of Cardiology, Sanbon Hospital, Wonkwang University College of Medicine
Gunpo, Gyeonggi-do, Korea, Republic of
Cardiovascular Center, Korea University Guro Hospital
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
  More Information

No publications provided

Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01882790     History of Changes
Other Study ID Numbers: HTN-CAS
Study First Received: June 14, 2013
Last Updated: August 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Coronary Vasospasm
Hypertension
Spasm
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014