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Long-term Fasting in Patients With a History of PCI

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
fasting
not fasting
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring prolonged fasting, percutaneous coronary angioplasty, major adverse cardiac events

Eligibility Criteria

53 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Professor kojuri cardiology clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fasting group

non fasting

Arm Description

those preferred to take long time fasting

those preferred not to take fasting

Outcomes

Primary Outcome Measures

The number of participant with major adverse cardiovascular event

Secondary Outcome Measures

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
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

Full Information

First Posted
February 19, 2021
Last Updated
February 25, 2021
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04772924
Brief Title
Long-term Fasting in Patients With a History of PCI
Official Title
Is Prolonged Fasting Safe in Patients Who Underwent Percutaneous Coronary Intervention More Than One Year Earlier?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
May 24, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
prolonged fasting, percutaneous coronary angioplasty, major adverse cardiac events

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
triple blind
Allocation
Non-Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fasting group
Arm Type
Experimental
Arm Description
those preferred to take long time fasting
Arm Title
non fasting
Arm Type
Active Comparator
Arm Description
those preferred not to take fasting
Intervention Type
Behavioral
Intervention Name(s)
fasting
Intervention Description
more than 12 hour of fasting as ceremony of Ramadan
Intervention Type
Behavioral
Intervention Name(s)
not fasting
Intervention Description
preferred not to take long term fasting
Primary Outcome Measure Information:
Title
The number of participant with major adverse cardiovascular event
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Dyspnea
Description
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
Time Frame
1 month
Title
Angina based on patient report, based on Canadian heart class
Description
1 no chest pain, 2 chest pain at maximal exercise, 3 chest pain at submaximal exercise, 4 chest pain at rest
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
53 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Professor kojuri cardiology clinic
City
Shiraz
State/Province
Outside Of The US
ZIP/Postal Code
55318
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Long-term Fasting in Patients With a History of PCI

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