Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04772924 |
Other study ID # |
IR.SUMS.MED.REC.1398.465 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 20, 2020 |
Est. completion date |
January 1, 2021 |
Study information
Verified date |
February 2021 |
Source |
Shiraz University of Medical Sciences |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Patients in this prospective cohort study were selected if they had a history of PCI more
than 1 year previously. 405 patients were divided based on their preferences to fasting and
non fasting and after 1 month of fasting major adverse cardiovascular events were measured
Description:
Between 18 March 2019 and 18 April 2020, patients seen at Professor Kojuri Cardiovascular
Clinic in Shiraz, Iran (email:kojurij@yahoo.com, webpage: http://kojuriclinic.com) for their
annual check-up were selected. We explained the research project to them, and volunteers were
selected. Patients were assigned to the fasting or non-fasting group according to their
preference. All volunteers were informed about the details of this research, and provided
their written informed consent. Patients who declined to participate in the study were
excluded.
Patients were instructed how to divide their medication across the two daily meals before
dawn and after sunset during the month of Ramadan. We informed patients to immediately stop
fasting and consult the clinic if they experienced any signs of cardiovascular disease,
including shortness of breath, chest pain, or palpitations. At the end of Ramadan, patients
were contacted by telephone and asked about their symptoms, including chest pain and dyspnea,
hospitalization, and MACE. The MACE were defined as acute myocardial infarction,
hospitalization due to congestive heart failure, new-onset atrial fibrillation, stroke, or
cardiac arrest [19, 20]. Symptomatic patients were referred to the clinic for cardiovascular
examination.
The study was double-blinded. To blind the researchers, the clinic secretary contacted the
patients and asked them not to specify their group (fasting or non-fasting), and then passed
the phone to the researcher. We used alphabetical order in each group to blind the
statisticians. Patients who fasted during Ramadan were designated with the letter X, and
patients who did not fast during Ramadan were designated with the letter Y.
For statistical analyses we used IBM SPSS software version 25. We used the chi-squared test
to compare categorical variables and Student's t-test to compare the mean values of
continuous variables. The Mann-Whitney U test and Kruskal-Wallis test were used for
nonparametric variables.