Coronary Artery DiseaseBSUNCT05531552
The Role of Clinical Pharmacist in Monitoring Drug Therapy in the Cardiovascular and Coronary Care Units in Libya.
An observational study of Coronary Artery Disease, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Assessment of role of clinical pharmacist in decreasing morbidity and mortality among coronary artery disease patients. Read more about this study
- Who is it for?
- Ages 41 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- clinical pharmacy application
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.).
Who may be able to join
- The inclusion criteria were all adults ≥40 years of age, with a diagnosis of CAD.
Who cannot join
- exclusion criteria were patients with various comorbidities such as liver or kidney disease; patients intake alcohol, cardiac surgery and refusal to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of role of clinical pharmacist in decreasing morbidity and mortality among coronary artery disease patients.
Read the detailed description
- Methodology: Follow-up patients from (A to Z) and their risk factors in all phases of disease (CAD) in groups with advised patients to lose weight, decrease smoking, and take medication on time.
Monitoring drugs to CAD by studying its Pharmacodynamic:
Mechanism of action, therapeutic uses [indication], adverse effect and suitable doses, and drug-drug interactions and contraindications
- The study shows the Compare between the patients in (Medical Center Hospital) with and without guidelines of clinical pharmacy. Were managed all by setting a plan with the cardiologist in Libya.
Follow-up was for the one hundred patients in the three groups {Outpatient, Inpatient, and the patients in Cardio Care Unit - CCU}.
- First subgroup, Outpatient: monitored the drugs used in HTN, DM, and Hyperlipidemia (dyslipidemia) to decrease levels of patients who come to the hospital with IHD; therefore, reduce morbidity. Also, it was followed by measurement of BP twice weekly, test for Blood sugar (glucose level) once monthly, and tests the Low-Density Lipoprotein (LDL) at the cardiologist's request.
- Second subgroup, Inpatient: monitored drugs according to international guidelines of clinical pharmacy to decrease the medication errors and management of the drug of stable angina and protected patients from increasing the problem, myocardial infarction, and reduce rates of entry to CCU.
- Third subgroup, Patients in CCU: Practiced the international roles of clinical pharmacy to monitor drug use to unstable Angina and MI, to decrease mortality in Libya.
- Method of analysis:
Were monitored one hundred patients and divided into:
- Twenty patients from (outpatient) divided to (10pts.-10pts.). (Ten patients) was written the data collected in accordance with the system adopted at the (Medical Center Hospital). (Ten patients)They are patients who applied the guidelines of clinical pharmacy to them in (Medical Center Hospital) by recommending cardiologists practice the clinical pharmacy guidelines and tailoring doses.
- 50 of inpatients as outpatient (25pts.-25pts.).
- 30 patients in CCU divided into (15pts.-15pts.).
- The statistical analysis was the comparison between the two groups:
- The first group of patients was undergoing treatment in the (Medical Center Hospital) without applying guidelines. (10 patients-25pts.-15pts.).
- The second group; are a group of patients undergoing treatment in the (Medical Center Hospital) in accordance with guidelines. (10pts.-25pts.-15pts.).
The comparison was in terms of the rate of survival, the speed of symmetry to heal ( i,e. responsiveness to medications), the rate of complications, and death for both groups.
- The purpose of this review is to summarize the role of clinical pharmacy benefits in all aspects of cardiovascular diseases (CVD) in hospitalized patients.
Managed the risk factors (hypertension, diabetes, dyslipidemia) and Ischemic heart disease by monitoring the common drugs in Libya:
- Diuretics: ACEIs and ARBs for hypertension.
- Insulin and Biguanides (Metformin) for diabetes.
- Statins for dyslipidemia.
- Organic nitrates: CCB, BB, Antiplatelets, Anticoagulant, and Fibrinolytics for ischemic heart disease.
And the summary of the aim of the work is the practice of guidelines of clinical pharmacy to manage coronary artery disease to reduce levels of morbidity and mortality in Libya and to prove the need for the presence of clinical pharmacists in Libyan hospitals.
- Conditions
- Coronary Artery Disease
- Being tested
- clinical pharmacy application
- Keywords
- clinical pharmacist role, ICU patients, CAD patients,
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical pharmacy applicationDrug
Also called Follow-up patients and their drugs, to improve health and reduce morbidity and mortality.
assessment clinical pharmacist in management of CAD and ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: clinical pharmacy application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 18 months, from Jan 2021 to June 2022.
The mortality.
The causes of death are cardiogenic shock, ventricular tachycardia, and myocardial infarction.
Measured: 18 months, from Jan 2021 to June 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Hospital, libya, Cairo University
- Responsible party
- Principal investigator, Asmaa S.H. Alhomri, Beni-Suef University
- Investigators
- Asmaa S. alhomri, BCH.PH, Principal investigator, Bachelor of Pharmaceutical Sciences, Faculty of Pharmacy, Omar Elmokhtar University, Tobruk, Libya.Raghda S. Hussien, Lecturer, Study director, Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.Eman K. Abdelall, Professor, Study director, Organic Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.Ahmed A. Battah, Professor, Study director, Critical Care Department, Faculty of Medicine, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531552
- Sponsor's protocol ID
- Clinical pharmacist role & ICU
- Acronym
- BSU
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Clinical Pharmacist in Monitoring Drug Therapy in the Cardiovascular and Coronary Care Units in Libya.
- ClinicalTrials.gov ID
- NCT05531552
- Acronym / sponsor ID
- BSU / Clinical pharmacist role & ICU
- Conditions
- Coronary Artery Disease
- Keywords
- clinical pharmacist role, ICU patients, CAD patients,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Medical Center Hospital, libya, Cairo University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of role of clinical pharmacist in decreasing morbidity and mortality among coronary artery disease patients.
Detailed description
- Methodology: Follow-up patients from (A to Z) and their risk factors in all phases of disease (CAD) in groups with advised patients to lose weight, decrease smoking, and take medication on time.
Monitoring drugs to CAD by studying its Pharmacodynamic:
Mechanism of action, therapeutic uses [indication], adverse effect and suitable doses, and drug-drug interactions and contraindications
- The study shows the Compare between the patients in (Medical Center Hospital) with and without guidelines of clinical pharmacy. Were managed all by setting a plan with the cardiologist in Libya.
Follow-up was for the one hundred patients in the three groups {Outpatient, Inpatient, and the patients in Cardio Care Unit - CCU}.
- First subgroup, Outpatient: monitored the drugs used in HTN, DM, and Hyperlipidemia (dyslipidemia) to decrease levels of patients who come to the hospital with IHD; therefore, reduce morbidity. Also, it was followed by measurement of BP twice weekly, test for Blood sugar (glucose level) once monthly, and tests the Low-Density Lipoprotein (LDL) at the cardiologist's request.
- Second subgroup, Inpatient: monitored drugs according to international guidelines of clinical pharmacy to decrease the medication errors and management of the drug of stable angina and protected patients from increasing the problem, myocardial infarction, and reduce rates of entry to CCU.
- Third subgroup, Patients in CCU: Practiced the international roles of clinical pharmacy to monitor drug use to unstable Angina and MI, to decrease mortality in Libya.
- Method of analysis:
Were monitored one hundred patients and divided into:
- Twenty patients from (outpatient) divided to (10pts.-10pts.). (Ten patients) was written the data collected in accordance with the system adopted at the (Medical Center Hospital). (Ten patients)They are patients who applied the guidelines of clinical pharmacy to them in (Medical Center Hospital) by recommending cardiologists practice the clinical pharmacy guidelines and tailoring doses.
- 50 of inpatients as outpatient (25pts.-25pts.).
- 30 patients in CCU divided into (15pts.-15pts.).
- The statistical analysis was the comparison between the two groups:
- The first group of patients was undergoing treatment in the (Medical Center Hospital) without applying guidelines. (10 patients-25pts.-15pts.).
- The second group; are a group of patients undergoing treatment in the (Medical Center Hospital) in accordance with guidelines. (10pts.-25pts.-15pts.).
The comparison was in terms of the rate of survival, the speed of symmetry to heal ( i,e. responsiveness to medications), the rate of complications, and death for both groups.
- The purpose of this review is to summarize the role of clinical pharmacy benefits in all aspects of cardiovascular diseases (CVD) in hospitalized patients.
Managed the risk factors (hypertension, diabetes, dyslipidemia) and Ischemic heart disease by monitoring the common drugs in Libya:
- Diuretics: ACEIs and ARBs for hypertension.
- Insulin and Biguanides (Metformin) for diabetes.
- Statins for dyslipidemia.
- Organic nitrates: CCB, BB, Antiplatelets, Anticoagulant, and Fibrinolytics for ischemic heart disease.
And the summary of the aim of the work is the practice of guidelines of clinical pharmacy to manage coronary artery disease to reduce levels of morbidity and mortality in Libya and to prove the need for the presence of clinical pharmacists in Libyan hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Drug: clinical pharmacy applicationapplication of clinical pharmacy guidelines and management CAD. Subgroup: 10 outpatient, 25 inpatient, 15 patient in CCU. |
Who may qualify
- Ages
- 41 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.).
Key inclusion criteria (1 listed)
- The inclusion criteria were all adults ≥40 years of age, with a diagnosis of CAD.
Key exclusion criteria (1 listed)
- exclusion criteria were patients with various comorbidities such as liver or kidney disease; patients intake alcohol, cardiac surgery and refusal to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical pharmacy applicationAlso: Follow-up patients and their drugs, to improve health and reduce morbidity and mortality.assessment clinical pharmacist in management of CAD and ICU patients. | Drug | Group II (observation group) |
Primary outcome
Angina pectoris.
Time frame: 18 months, from Jan 2021 to June 2022.
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.
Responsiveness to medications.
Time frame: 18 months, from Jan 2021 to June 2022.
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)
The incidence of complications.
Time frame: 18 months, from Jan 2021 to June 2022.
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).
The mortality.
Time frame: 18 months, from Jan 2021 to June 2022.
The causes of death are cardiogenic shock, ventricular tachycardia, and myocardial infarction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa S. alhomri, BCH.PH principal investigator
Bachelor of Pharmaceutical Sciences, Faculty of Pharmacy, Omar Elmokhtar University, Tobruk, Libya.
Raghda S. Hussien, Lecturer study director
Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.
Eman K. Abdelall, Professor study director
Organic Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angina pectoris. (time frame: 18 months, from Jan 2021 to June 2022.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.