Coronary Artery DiseaseNCT04772924
Long-term Fasting in Patients With a History of PCI
A study testing fasting and not fasting in people with Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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 Read more about this study
- Who is it for?
- Ages 53 to 74 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- fasting and not fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteIran
- Study dates
- 20 Apr 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 53 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of PCI, and a minimum of 1 year between angioplasty and enrollment in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- fasting, not fasting
- Keywords
- prolonged fasting, percutaneous coronary angioplasty, major adverse cardiac events
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fastingBehavioural
more than 12 hour of fasting as ceremony of Ramadan
not fastingBehavioural
preferred not to take long term fasting
| Study group | Role | What they receive |
|---|---|---|
| fasting group | Experimental | those preferred to take long time fasting Receives: Behavioral: fasting |
| non fasting | Active comparator | those preferred not to take fasting Receives: Behavioral: not fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participant with major adverse cardiovascular event
Measured: 1 month
Secondary outcomes (2)
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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start20 Apr 2020
- Primary completion24 May 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772924
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1398.465
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Prolonged Fasting Safe in Patients Who Underwent Percutaneous Coronary Intervention More Than One Year Earlier?
- ClinicalTrials.gov ID
- NCT04772924
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1398.465
- Conditions
- Coronary Artery Disease
- Keywords
- prolonged fasting, percutaneous coronary angioplasty, major adverse cardiac events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fasting group | Experimental | Behavioral: fastingthose preferred to take long time fasting |
| non fasting | Active comparator | Behavioral: not fastingthose preferred not to take fasting |
Who may qualify
- Ages
- 53 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- history of PCI, and a minimum of 1 year between angioplasty and enrollment in this study
Key exclusion criteria (8 listed)
- Heart failure (ejection fraction <50 %)
- Advanced kidney failure (glomerular filtration rate <60 mL/min
- Unsuccessful revascularization
- Coronary artery bypass graft
- Liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fastingmore than 12 hour of fasting as ceremony of Ramadan | Behavioural | fasting group |
| not fastingpreferred not to take long term fasting | Behavioural | non fasting |
Primary outcome
The number of participant with major adverse cardiovascular event
Time frame: 1 month
2 secondary outcomes
Dyspnea
Time frame: 1 month
Angina based on patient report, based on Canadian heart class
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting and not fasting in people with Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participant with major adverse cardiovascular event (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.