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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04772924
Enrollment
405
Registered
2021-02-26
Start date
2020-04-20
Completion date
2021-01-01
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

prolonged fasting, percutaneous coronary angioplasty, major adverse cardiac events

Brief 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

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.

Interventions

BEHAVIORALfasting

more than 12 hour of fasting as ceremony of Ramadan

BEHAVIORALnot fasting

preferred not to take long term fasting

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

triple blind

Eligibility

Sex/Gender
ALL
Age
53 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The number of participant with major adverse cardiovascular event1 month

Secondary

MeasureTime frameDescription
Dyspnea1 monthGrade 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
Angina based on patient report, based on Canadian heart class1 month1 no chest pain, 2 chest pain at maximal exercise, 3 chest pain at submaximal exercise, 4 chest pain at rest

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026