This trial is active, not recruiting.

Condition acute coronary syndrome
Treatment pharmaceutical care service
Sponsor Ain Shams University
Collaborator Ain Shams university hospital
Start date September 2015
End date August 2017
Trial size 40 participants
Trial identifier NCT02922140, PHCL49


This study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with Acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or cardiac events.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(No Intervention)
will receive standard care by physician in attendance
(Active Comparator)
will be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance.
pharmaceutical care service pharmaceutical care plan

Primary Outcomes

Change in the level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q)
time frame: three months
Change in anthropometric measurements (body mass index [BMI] (Kg/m^2))
time frame: three months
Change in systolic and diastolic blood pressure [BP] (mmHg).
time frame: three months
Change in levels of fasting blood glucose (mg/dl)
time frame: three months
Change in Lipid profile : total cholesterol (mg/dl), triglycerides(mg/dl), and low density lipoprotein cholesterol(mg/dl), high density lipoprotein (mg/dl)
time frame: three months
Change in Kidney function tests : serum urea (mg/dl).
time frame: three months
Change in Liver function tests: aspartate aminotransferase enzyme (AST) (u/l), alanine aminotransferase (ALT) (u/l)
time frame: three months
Change in the number of solved drug-related problems
time frame: three months
Change in waist circumference (cm).
time frame: Three months
Change in serum creatinine (mg/dl).
time frame: Three months
Change in sodium (mmol/l).
time frame: Three months
Change in potassium (mmol/l).
time frame: Three months
Change in heart rate [HR] (Bpm).
time frame: Three months

Secondary Outcomes

Assessment of quality of life: (36-items self-care Health survey (SF-36)).
time frame: three months
Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).
time frame: three months
Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).
time frame: three months

Eligibility Criteria

Male or female participants from 20 years up to 79 years old.

Inclusion Criteria: 1. Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft. 2. At 20-79 years of age. 3. Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist. 4. Willing to participate in this study. 5. Able to be reached by telephone postdischarge. Exclusion Criteria: 1. Patients with cognitive impairment. 2. If they need professional help to take their medication at home. 3. With terminal illness. 4. Inability to communicate. 5. Severe arrhythmia.

Additional Information

Official title The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
Principal investigator Eman A. Casper, bachelor
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ain Shams University.