Syndrome XNCT00190086
Syndrome X and Endothelial Dysfunction
An observational study of Syndrome X, run by Far Eastern Memorial Hospital.
Trial summary
Cardiac syndrome X is characterized by angina, positve stress test, and patent coronary angiography, and its probable mechanism is microvascular dysfunction associated with endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syndrome X
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- which was performed under the impression of CAD due to positive treadmill electrocardiography test or ischemic evidence on Thallium scan, yielded the result of patent coronary tree. After the confirmation of angina symptoms and double-blinded review of the stress test and angiography result by 2 cardiologists to exclude controversial result
Who cannot join
- -
About this study
Cardiac syndrome X is characterized by angina, positve stress test, and patent coronary angiography, and its probable mechanism is microvascular dysfunction associated with endothelial dysfunction. We used brachial artery flow-mediated vasodilation to assess the endothelial function of the patients with syndrome X, coronary artery disease, and controls. Methods: We enrolled 28 patients with syndrome X, 11 healthy volunteers and 11 coronary artery disease patients. All subjects underwent a 2-step brachial artery flow-related vasodilation test: ultrasound artery diameter was measured at rest and after occlusion to assess endothelium-dependent vasodilation and after sublingual nitroglycerin to determine endothelium-independent condition. Serum endothelin-1 assay was performed for all participants. Results: The cardiac syndrome X patients had lower brachial artery dilation ratio (diameter after test/ diameter before test) than controls (1.10 +/- 0.09 versus 1.27 +/- 0.11, p=0.013), but the ratio is still higher than CAD patients (1.10 +/- 0.09 versus 1.02 +/- 0.07, p<0.001). After sublingual nitroglycerin, all 50 subjects had adequate vasodilation. Besides, normal controls have higher endothelin-1 level than the others.
We concluded that syndrome X patients have worse endothelial function than healthy control, but patients of CAD had even worse endothelium function than cardiac syndrome X patients.
Keywords: Cardiac syndrome X, coronary artery disease, endothelium-dependent vasodilation, endothelium-independent vasodilation, flow-mediated vasodilation, endothelin-1
Read the detailed description
Cardiac syndrome x (CSX), which is defined as the combination of typical chest pain, electrocardiography or nuclear medicine evidence suggesting myocardial ischemia, and patent coronary arteriogram, comprises approximately 10-30% of the patients undergoing coronary angiogram.1,2 However, since it was first introduced in 1973, the pathogenesis of CSX has remained an enigma.1, 2 Among all the hypothetic explanations of CSX, including abnormal pain perception and non-cardiogenic origin of pain, the coronary microvascular dysfunction (microvascular angina), which represents reduced microvascular dilatory response and increased resistence, has been consistently found in CSX patients. 2, 3 This microvascular angina is believed to bridge the gap between the ischemic evidence and the normal-looking of coronary tree of CSX, and seems attributed to the endothelium dysfunction (ED), another frequently reported abnormality in CSX.2.3 By definition, ED is characterized by the endothelium-dependent vasodilation (EDVD) impairment, which is believed to be caused by decreased release of NO activity and/or activity, while the endotheliumindependent vasodilation (EIVD) remains preserved. 2,3,4 Therefore, it is asserted that endothelium-dependent dilatation of the resistance coronary arteries is defective in patients with CSX, and such defects may contribute to the altered regulation of myocardial perfusion in these patients.5 On the other hand, ED play a pivotal role in the development, progression, and clinical manifestations of atherosclerosis, as well as in the development of ischemia and thrombosis in the late stages of the disease, by promoting coronary vasoconstriction and thrombosis.4 Instead of using invasively intravascular measuring method used for endothelial function assessment, Celermajer et al first introduced the non-invasive measurement of the flow-mediated vasodilation (FMD) of forearm brachial artery in the assessment of EDVD and EIVD.6 This method was reported to have good correlation to the invasively intravascular studies in coronary systems.4 In this study, we want to compare the difference of forearm FMD, which respond to specially programmed stimuli, in three patient groups: CSX, coronary artery disease (CAD), and normal volunteers. A two-staged stimulation strategy is utilized to assess the EDVD (with cuff occlusion) and EIVD (with sublingual nitroglycerin) consecutively. A baseline plasma endothelin-1 (ET-1) concentration is also checked for each patient enrolled.
- Conditions
- Syndrome X
- Medical subject headings
- Microvascular Angina
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- A H Li, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190086
- Sponsor's protocol ID
- FEMH-94001
- Status last verified
- Dec 2001
- First submitted
- 11 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndrome X and Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT00190086
- Acronym / sponsor ID
- FEMH-94001
- Conditions
- Syndrome X
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 28 participants
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Dec 2001
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac syndrome X is characterized by angina, positve stress test, and patent coronary angiography, and its probable mechanism is microvascular dysfunction associated with endothelial dysfunction. We used brachial artery flow-mediated vasodilation to assess the endothelial function of the patients with syndrome X, coronary artery disease, and controls. Methods: We enrolled 28 patients with syndrome X, 11 healthy volunteers and 11 coronary artery disease patients. All subjects underwent a 2-step brachial artery flow-related vasodilation test: ultrasound artery diameter was measured at rest and after occlusion to assess endothelium-dependent vasodilation and after sublingual nitroglycerin to determine endothelium-independent condition. Serum endothelin-1 assay was performed for all participants. Results: The cardiac syndrome X patients had lower brachial artery dilation ratio (diameter after test/ diameter before test) than controls (1.10 +/- 0.09 versus 1.27 +/- 0.11, p=0.013), but the ratio is still higher than CAD patients (1.10 +/- 0.09 versus 1.02 +/- 0.07, p<0.001). After sublingual nitroglycerin, all 50 subjects had adequate vasodilation. Besides, normal controls have higher endothelin-1 level than the others.
We concluded that syndrome X patients have worse endothelial function than healthy control, but patients of CAD had even worse endothelium function than cardiac syndrome X patients.
Keywords: Cardiac syndrome X, coronary artery disease, endothelium-dependent vasodilation, endothelium-independent vasodilation, flow-mediated vasodilation, endothelin-1
Detailed description
Cardiac syndrome x (CSX), which is defined as the combination of typical chest pain, electrocardiography or nuclear medicine evidence suggesting myocardial ischemia, and patent coronary arteriogram, comprises approximately 10-30% of the patients undergoing coronary angiogram.1,2 However, since it was first introduced in 1973, the pathogenesis of CSX has remained an enigma.1, 2 Among all the hypothetic explanations of CSX, including abnormal pain perception and non-cardiogenic origin of pain, the coronary microvascular dysfunction (microvascular angina), which represents reduced microvascular dilatory response and increased resistence, has been consistently found in CSX patients. 2, 3 This microvascular angina is believed to bridge the gap between the ischemic evidence and the normal-looking of coronary tree of CSX, and seems attributed to the endothelium dysfunction (ED), another frequently reported abnormality in CSX.2.3 By definition, ED is characterized by the endothelium-dependent vasodilation (EDVD) impairment, which is believed to be caused by decreased release of NO activity and/or activity, while the endotheliumindependent vasodilation (EIVD) remains preserved. 2,3,4 Therefore, it is asserted that endothelium-dependent dilatation of the resistance coronary arteries is defective in patients with CSX, and such defects may contribute to the altered regulation of myocardial perfusion in these patients.5 On the other hand, ED play a pivotal role in the development, progression, and clinical manifestations of atherosclerosis, as well as in the development of ischemia and thrombosis in the late stages of the disease, by promoting coronary vasoconstriction and thrombosis.4 Instead of using invasively intravascular measuring method used for endothelial function assessment, Celermajer et al first introduced the non-invasive measurement of the flow-mediated vasodilation (FMD) of forearm brachial artery in the assessment of EDVD and EIVD.6 This method was reported to have good correlation to the invasively intravascular studies in coronary systems.4 In this study, we want to compare the difference of forearm FMD, which respond to specially programmed stimuli, in three patient groups: CSX, coronary artery disease (CAD), and normal volunteers. A two-staged stimulation strategy is utilized to assess the EDVD (with cuff occlusion) and EIVD (with sublingual nitroglycerin) consecutively. A baseline plasma endothelin-1 (ET-1) concentration is also checked for each patient enrolled.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- which was performed under the impression of CAD due to positive treadmill electrocardiography test or ischemic evidence on Thallium scan, yielded the result of patent coronary tree. After the confirmation of angina symptoms and double-blinded review of the stress test and angiography result by 2 cardiologists to exclude controversial result
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
Related trials for Syndrome X
RecruitingObservational study
Neurophysiologic Biomarkers in Rett Syndrome
Rett Syndrome, RTT
Active, not recruitingObservational study
The DISCOVER INOCA Prospective Multi-center Registry
Ischemia and No Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction
RecruitingPhase 1/2
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
X-linked Severe Combined Immunodeficiency (XSCID)
RecruitingObservational study
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
Microvascular Angina
Not yet recruitingPhase 1
Prophylactic DLI-X for Leukemia Relapse After HCT
Acute Lymphoid Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A H Li, MD principal investigator
Far Eastern Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Syndrome X, run by Far Eastern Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2005.