NCT05531552

Brief Summary

Assessment of role of clinical pharmacist in decreasing morbidity and mortality among coronary artery disease patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
Last Updated

July 27, 2023

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

August 30, 2022

Last Update Submit

July 26, 2023

Conditions

Keywords

clinical pharmacist role, ICU patients, CAD patients,

Outcome Measures

Primary Outcomes (4)

  • Angina pectoris.

    Periodically data collected. \[ex: the measurements of blood pressure, glucose blood serum, and LDL - (and taken the average during the period)\]. The parameters in the research (angina, response to treatment, complication rate, and mortality) - were quantitatively collected, as the results added to the paper contain the number of patients with details of their complications or the cause of death of patients who died). The measuring of FBG level (mg/dl), and (LDL-C) mg/dl - was then performed using a fully automated chemistry analysis instrument by Roche company (Cobas Integra 400 plus). And using specific kits for blood glucose levels (System ID 07-6831-6) and using kits for (LDL-C) (System ID 07-6726-3), Troponin (ng\\ml) was performed by using (Beckman coulter - Access 2). Angina pectoris was more predominant in patients in group (I); vs. in group (II) with a statistically significant difference.

    18 months, from Jan 2021 to June 2022.

  • Responsiveness to medications.

    Periodically data collected. \[ex: the measurements of blood pressure, diabetes, lipid profile, and weight - (and taken the average during the period)\]. The parameters in the research (angina, response to treatment, complication rate, and mortality) - were quantitatively collected, as the results added to the paper contain the number of patients with details of their complications or the cause of death of patients who died). Follow-up patients, their clinical state and side effects of medications, Following the number of Hospitalization decreased. Responsiveness to medications was significantly higher among patients from the group (II); compared with a control group (I)

    18 months, from Jan 2021 to June 2022.

  • The incidence of complications.

    The complications are noticeable: myocardial infarctions \[Troponin was perpetrated by using by (Beckman coulter)(Access 2) ng\\ml\], cardiac arrhythmias \[by ECG\], cardiogenic shock \[after MI with HF and low BP\], HTN crisis {BP measure, DKA \[high blood glucose with (+) positive Ketones. Data were collected quantitatively, as the results added to the paper contain the number of patients with details of their complications).

    18 months, from Jan 2021 to June 2022.

  • The mortality.

    The causes of death are cardiogenic shock, ventricular tachycardia, and myocardial infarction.

    18 months, from Jan 2021 to June 2022.

Study Arms (2)

Group I (control group)

was collect data without any interference (without clinical pharmacy guidelines). Subgroup: 10 outpatient, 25 inpatient, 15 patient in CCU.

Group II (observation group)

application of clinical pharmacy guidelines and management CAD. Subgroup: 10 outpatient, 25 inpatient, 15 patient in CCU.

Drug: clinical pharmacy application

Interventions

assessment clinical pharmacist in management of CAD and ICU patients.

Also known as: Follow-up patients and their drugs, to improve health and reduce morbidity and mortality.
Group II (observation group)

Eligibility Criteria

Age41 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Follow-up one hundred patients, in two groups, divided each one into three subgroups {10-Outpatient, 25-Inpatient and 15 patients in Cardio Care Unit - CCU}. * The first group of patients was undergoing treatment in the (Medical Center Hospital) without applying clinical pharmacy guidelines. (10 patients-25pts.-15pts.). * The second group; are a group of patients undergoing treatment in the (Medical Center Hospital) in accordance with clinical pharmacy guidelines. (10pts.-25pts.-15pts.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university

Banī Suwayf, +20, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Mortality

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Vital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Asmaa S. alhomri, BCH.PH

    Bachelor of Pharmaceutical Sciences, Faculty of Pharmacy, Omar Elmokhtar University, Tobruk, Libya.

    PRINCIPAL INVESTIGATOR
  • Raghda S. Hussien, Lecturer

    Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.

    STUDY DIRECTOR
  • Eman K. Abdelall, Professor

    Organic Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.

    STUDY DIRECTOR
  • Ahmed A. Battah, Professor

    Critical Care Department, Faculty of Medicine, Cairo University, Cairo, Egypt

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BCH.PH & pharmaceutical science, Faculty of Pharmacy, Omar Elmokhtar University, Tobruk, Libya.

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 8, 2022

Study Start

January 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 27, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations