Cardiovascular DiseasesHIRICS-XNCT02095964
HDL-C in Cardiac Syndrome X
An observational study of Cardiovascular Diseases and Heart Diseases, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial generation of nitric oxide (NO) and improves endothelial function and arterial vasoreactivity[11]. Read more about this study
- Who is it for?
- Ages 47 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischaemia
- How many people
- 710 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 2014
- 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 47 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: CSX was defined as typical chest pain during rest or effort, abnormal test result for exercise ECG and myocardial perfusion scintigraphy, and the presence of angiographically normal epicardial coronary arteries. Control group was selected from volunteers presented to our hospital with the complaint of typical anginal chest pain who had no ischemia on myocardial perfusion scintigraphy or during the treadmill exercise test, had similar risk profile with the patients (diabetes, hypertension, age, gender) and had normal epicardial coronaries at coronary angiography.
Who may be able to join
- Must be able to get exercise stress test
- Must be able to have coronary angiography
- Clinical diagnosis of typical anginaduring rest or effort
- Abnormal test result for exercise ECG or myocardial perfusion scintigraphy
- Must have of angiographically normal epicardial coronary arteries
Who cannot join
- Patients with valvular heart disease (mitral stenosis and moderate to severe mitral regurgitation
- Patients with moderate to severe aortic stenosis and regurgitation including mitral annular calcification)
- Patients with heart failure (left ventricular ejection fraction <50%)
- Patients with congenital heart disease, cardiomyopathy, left ventricular hypertrophy, right ventricular hypertrophy
- Patients with cardiac surgery
- Patients with thyroid disease
Show all 9Show fewer
- Patients with anemia
- Patients with pulmonary diseases
- Patients with infectious diseases (locally or systemic)
About this study
Official title: HDL-Cholesterol is Inversely Related With Inflammation in Cardiac Syndrome X
High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial generation of nitric oxide (NO) and improves endothelial function and arterial vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and E-selectin[15].
In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory markers in patients with cardiac syndrome X (CSX).
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischaemia, Unstable Angina, Microvascular Angina
- Keywords
- cardiac syndrome X, inflammation, dyslipidemia
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Angina, Unstable, Microvascular Angina, Inflammation, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Syndrome X | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-Cholesterol
HDL-Cholesterol <40 mg/dL(male) / < 50mg/dL(female) ==> low HDL-C
Measured: 6 MONTHS
Cardiac Syndrome X
Patients who have typical anginal chest pain+ischaemic findings at exercise stress test/myocardial scintigraphy + normal epicardial coronaries at coronary angiography ==> Cardiac syndrome X
Measured: 6 months
Inflammation
CRP > 2,98 mg/dL ==> systemic inflammation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 710 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095964
- Sponsor's protocol ID
- BYIEAH-281
- Acronym
- HIRICS-X
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HDL-Cholesterol is Inversely Related With Inflammation in Cardiac Syndrome X
- ClinicalTrials.gov ID
- NCT02095964
- Acronym / sponsor ID
- HIRICS-X / BYIEAH-281
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischaemia, Unstable Angina, Microvascular Angina
- Keywords
- cardiac syndrome X, inflammation, dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Mar 2014 (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.
High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial generation of nitric oxide (NO) and improves endothelial function and arterial vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and E-selectin[15].
In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory markers in patients with cardiac syndrome X (CSX).
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Syndrome X | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 47 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- CSX was defined as typical chest pain during rest or effort, abnormal test result for exercise ECG and myocardial perfusion scintigraphy, and the presence of angiographically normal epicardial coronary arteries. Control group was selected from volunteers presented to our hospital with the complaint of typical anginal chest pain who had no ischemia on myocardial perfusion scintigraphy or during the treadmill exercise test, had similar risk profile with the patients (diabetes, hypertension, age, gender) and had normal epicardial coronaries at coronary angiography.
Key inclusion criteria (5 listed)
- Must be able to get exercise stress test
- Must be able to have coronary angiography
- Clinical diagnosis of typical anginaduring rest or effort
- Abnormal test result for exercise ECG or myocardial perfusion scintigraphy
- Must have of angiographically normal epicardial coronary arteries
Key exclusion criteria (9 listed)
- Patients with valvular heart disease (mitral stenosis and moderate to severe mitral regurgitation
- Patients with moderate to severe aortic stenosis and regurgitation including mitral annular calcification)
- Patients with heart failure (left ventricular ejection fraction <50%)
- Patients with congenital heart disease, cardiomyopathy, left ventricular hypertrophy, right ventricular hypertrophy
- Patients with cardiac surgery
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
HDL-Cholesterol
Time frame: 6 MONTHS
HDL-Cholesterol <40 mg/dL(male) / < 50mg/dL(female) ==> low HDL-C
Cardiac Syndrome X
Time frame: 6 months
Patients who have typical anginal chest pain+ischaemic findings at exercise stress test/myocardial scintigraphy + normal epicardial coronaries at coronary angiography ==> Cardiac syndrome X
Inflammation
Time frame: 6 months
CRP > 2,98 mg/dL ==> systemic inflammation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Bursa Yuksek Ihtisas Training and Research 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 26 Mar 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
HDL-Cholesterol (time frame: 6 MONTHS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 26 Mar 2014.