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Trial record 8 of 148 for:    Recruiting, Not yet recruiting, Available Studies | "Drinking Water"

Serum Magnesium Levels in Desalination Tap Water and Outcomes in Acute Myocardial Infarction Patients

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ClinicalTrials.gov Identifier: NCT02356393
Recruitment Status : Recruiting
First Posted : February 5, 2015
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
EHF - Environment and Health Fund
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with 1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW) (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya MC).

Condition or disease
Myocardial Infarction Death Congestive Heart Failure Acute-MI Cardiovascular Disease

Detailed Description:
Extensive seawater desalination in Israel may decrease magnesium in drinking water (DW), causing hypomagnesemia and adverse health effects. We study the association between consumption of desalinated drinking water (DSW) and serum magnesium in acute MI (AMI) patients, Subjects 35-75 years of age with the first AMI will be prospectively recruited during 1 year from 2 regions; the Departments of Cardiology at the Sheba Medical center (300 patients, predominantly served by DSW) and the Nahariya Medical Center (150 patients, served by non-DSW). Questionnaire will be developed to collect data on demographic variables (at home and work), water and beverages consumption habits (tap water, mineral water), dietary sources of Mg and Mg supplementations. Mg levels will be measured in DW from the patients' homes and in their serum on admission.

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Magnesium Serum Levels on Clinical Outcomes in Patients With Acute Myocardial Infarction by Considering Desalination Drinking Water Levels Patients Fed From.
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium




Primary Outcome Measures :
  1. Number of Major Adverse Cardiovascular Events (MACE) [ Time Frame: 1 year ]
    MACE including: acute infarct returns, revascularization, death within 30 days or one year, hospitalization for heart failure, hospitalization for angina pectoris and transient ischemic events.


Secondary Outcome Measures :
  1. Age [ Time Frame: 1 year ]
    Age at the first Acute Myocardial Infraction



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Subjects 35-75 years of age with the first AMI will be prospectively recruited during 1 year from 2 regions; the Departments of Cardiology at the Sheba Medical center (300 patients, predominantly served by DSW) and the Nahariya Medical Center (150 patients, served by non-DSW).
Criteria

Inclusion Criteria:

  1. Patients with first AMI
  2. Age 35-75

Exclusion Criteria:

1. Patients > age 75


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356393


Contacts
Contact: Michael Shechter, MD +97235302617 Michael.Shechter@sheba.health.gov.il
Contact: Shlomi Matetzky, MD +97235302504 Shlomi.Matetzky@sheba.health.gov.il

Locations
Israel
Leviev Heart Center, Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Michael Shechter, MD    +97235302617    Michael.Shechter@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
EHF - Environment and Health Fund
Investigators
Study Chair: Meital Shlezinger, PhDcandidate Haim Sheba medical Center

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02356393     History of Changes
Other Study ID Numbers: SHEBA-14-1545-MS-CTIL
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sheba Medical Center:
Desalinated Sea Water
Magnesium
Drinking Water

Additional relevant MeSH terms:
Heart Failure
Infarction
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases