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Long-term Fasting in Patients With a History of PCI

NCT ID: NCT04772924

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2021-01-01

Brief Summary

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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

Detailed Description

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Between 18 March 2019 and 18 April 2020, patients seen at Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email:[email protected], 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.

Conditions

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Coronary Artery Disease

Keywords

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prolonged fasting percutaneous coronary angioplasty major adverse cardiac events

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
triple blind

Study Groups

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fasting group

those preferred to take long time fasting

Group Type EXPERIMENTAL

fasting

Intervention Type BEHAVIORAL

more than 12 hour of fasting as ceremony of Ramadan

non fasting

those preferred not to take fasting

Group Type ACTIVE_COMPARATOR

not fasting

Intervention Type BEHAVIORAL

preferred not to take long term fasting

Interventions

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fasting

more than 12 hour of fasting as ceremony of Ramadan

Intervention Type BEHAVIORAL

not fasting

preferred not to take long term fasting

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* history of PCI, and a minimum of 1 year between angioplasty and enrollment in this study

Exclusion Criteria

* Heart failure (ejection fraction \<50 %)
* Advanced kidney failure (glomerular filtration rate \<60 mL/min
* Unsuccessful revascularization
* Coronary artery bypass graft
* Liver cirrhosis
* Any acute conditions such as infection
* Needed repetitive treatment
* Diabetes who were on insulin treatment
Minimum Eligible Age

53 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Javad Kojuri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Professor kojuri cardiology clinic

Shiraz, Outside of the US, Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.SUMS.MED.REC.1398.465

Identifier Type: -

Identifier Source: org_study_id