Long-term Fasting in Patients With a History of PCI

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: fasting; Behavioral: not fasting

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Outside Of The US
    • Shiraz, Outside Of The US, Iran, Islamic Republic of, 55318
      • Professor kojuri cardiology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): May 24, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: percutaneous coronary angioplasty; major adverse cardiac events; prolonged fasting
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: IR.SUMS.MED.REC.1398.465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No