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

December 10, 2023 updated by: Sheba Medical Center

The Effect of Magnesium Serum Levels on Clinical Outcomes in Patients With Acute Myocardial Infarction by Considering Desalination Drinking Water Levels Patients Fed From.

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).

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Leviev Heart Center, Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients > age 75

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 1 year
Age at the first Acute Myocardial Infraction
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Environment and Health Fund (EHF)

Investigators

  • Study Chair: Meital Shlezinger, PhDcandidate, Haim Sheba medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

February 1, 2015

First Posted (Estimated)

February 5, 2015

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 10, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1545-MS-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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