Advertisement

Topics

Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)

2014-08-27 03:13:59 | BioPortfolio

Summary

Vitamin D is known to have immune-modulator effects including suppression of proinflammatory cytokine expression and regulation of immune cell activity. Vitamin D supplementation has been associated with a reduction in pro-inflammatory cytokines in patients with heart failure, and vitamin D deficiency has been associated with higher rates of myocardial infarcts. The levels of pro and anti-inflammatory cytokines also effect the outcome after acute coronary events.

The proposed interventional study is targeted as a feasibility study targeted at assessing the role of vitamin D as an anti-inflammatory mediator.

The study is planned as a randomized open label interventional trial. The study will be conducted of 50 adult patients (25 interventional group, 25 control), all from the internal ward in "Meir" medical center. Patients which are admitted after an acute coronary event will be randomized to the Vitamin D supplementation group or to the control group. the vitamin D group will receive 4000IU per day of vitamin D for five days. Cytokine levels will be measured at day 1 and at day 5. follow up will be continued for 6 months

Primary end point:

Levels of immune mediating cytokines (CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10) after a five day intervention in patients serum.

Secondary endpoints:

Any major cardiovascular event within follow-up period. Any death of any cause during follow-up period

Expected results:

the investigators expect vitamin D supplementation after a pro-inflammatory state such as an acute coronary event, combined with conventional therapy, to result in decreased levels of inflammatory serum bio-markers.

Description

Inclusion criteria:

- Acute coronary syndrome (as defined previously).

- No advanced renal disease (creatinine levels < 1.8 for men and 1.5 for women).

- No known parathyroid or calcium homeostasis abnormalities

- Baseline Calcium levels within normal limits.

- No vitamin D supplementation taken within 4 months of current admission.

- No coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)

- No coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents).

- No participation in other interventional studies.

- Signing an informed consent form.

Exclusion criteria:

- Advanced renal failure

- Abnormal serum calcium levels upon admission

- Primary parathyroid or calcium homeostasis abnormalities.

- Coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)

- Coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents)

- Participation in other interventional studies.

- Inability or refusal to sign an informed consent.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Acute Coronary Syndrome

Intervention

Vitamin D

Location

Meir Medical Center
Kfar-Sava
Israel

Status

Not yet recruiting

Source

Meir Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

Clinical Trials [3930 Associated Clinical Trials listed on BioPortfolio]

Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement

The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).

Jakarta Acute Coronary Syndrome Registry

Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to the emergency department of a national cardiac referral hospital.

Investigation of the Heart and the Clinical Course of Acute Coronary Syndrome in Patients With Non-obstructive Lesion of the Coronary Arteries

The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship ...

RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy

This NIS is a multi-centre, observational, descriptive, cross-sectional study including all consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective, longitudi...

Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

The purpose of this study is to determine whether nonsteroidal antiinflammatory drug lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients with Acut...

PubMed Articles [12261 Associated PubMed Articles listed on BioPortfolio]

Destructive changes in epicardial arteries and coronary microcirculation in women with non st elevation acute coronary syndrome, depending on hormonal status.

Introduction: Acute forms of cardiovascular are a major problem in the structure of morbidity and mortality, especially among perimenopausal women. The most important is nature and features of the dam...

Optimal Medical Therapy and Secondary Prevention in Patients after an Acute Coronary Syndrome.

Antithrombotic therapy and other secondary preventive measures such as lifestyle changes, lipid lowering and blood pressure control, along with coronary revascularization strategies, can markedly impr...

Comparison of the planned one- and elective two-stent techniques in patients with coronary bifurcation lesions with or without acute coronary syndrome from the COBIS II Registry.

To evaluate the impacts of stent techniques on long-term clinical outcomes after percutaneous coronary intervention (PCI) using drug-eluting stents (DES) for coronary bifurcation lesions in patients w...

Etiology of Acute Coronary Syndrome after Noncardiac Surgery.

The objective of this investigation was to determine the etiology of perioperative acute coronary syndrome with a particular emphasis on thrombosis versus demand ischemia.

Non-vitamin K Antagonist Oral Anticoagulant After Acute Coronary Syndrome: Is There a Role?

Despite dual antiplatelet therapy (DAPT) including potent P2Y12 inhibitors, recurrent ischaemic events occur in a significant number of patients after acute coronary syndrome (ACS), warranting new ant...

Medical and Biotech [MESH] Definitions

A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

More From BioPortfolio on "Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Cytokine
Cytokines include chemokines, lymphokines, and monokines. Cells of the immune system communicate with one another by releasing and responding to chemical messengers called cytokines. These proteins are secreted by immune cells and act on other cells to...


Searches Linking to this Trial