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NCT02356393 Clinical Trial

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

Myocardial Infarction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02356393
Other study ID # SHEBA-14-1545-MS-CTIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date December 1, 2023

Study information
Verified date December 2023
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years to 75 Years
Eligibility Inclusion Criteria: 1. Patients with first AMI 2. Age 35-75 Exclusion Criteria: 1. Patients > age 75

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Leviev Heart Center, Chaim Sheba Medical Center Ramat Gan

Sponsors (2)
Lead Sponsor Collaborator
Sheba Medical Center Environment and Health Fund (EHF)

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Major Adverse Cardiovascular Events (MACE) 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. 1 year
Secondary Age Age at the first Acute Myocardial Infraction 1 year
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