Long-term Fasting in Patients With a History of PCI

Study Overview
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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: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.

Official Title
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Is Prolonged Fasting Safe in Patients Who Underwent Percutaneous Coronary Intervention More Than One Year Earlier?

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: fasting
* Behavioral: not fasting


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 53 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fasting group<br>those preferred to take long time fasting | Behavioral: fasting<br>* more than 12 hour of fasting as ceremony of Ramadan<br>|
| Active Comparator: non fasting<br>those preferred not to take fasting | Behavioral: not fasting<br>* preferred not to take long term fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participant with major adverse cardiovascular event |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Grade of dyspnea was measured based on patient report, based on New York heart association class, 1 no dyspnea, 2 dyspnea at heavy exertion, 3 dyspnea at sub maximal exertion, 4 dyspnea at rest | 1 month | 
| Angina based on patient report, based on Canadian heart class | 1 no chest pain, 2 chest pain at maximal exercise, 3 chest pain at submaximal exercise, 4 chest pain at rest | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged fasting, percutaneous coronary angioplasty, major adverse cardiac events