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临床试验/NCT04772924
NCT04772924已完成不适用

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

Shiraz University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
405
试验地点
2
主要终点
The number of participant with major adverse cardiovascular event

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

triple blind

入排标准

年龄范围
53 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • history of PCI, and a minimum of 1 year between angioplasty and enrollment in this study

排除标准

  • 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

结局指标

主要结局

The number of participant with major adverse cardiovascular event

时间窗: 1 month

次要结局

  • Angina based on patient report, based on Canadian heart class(1 month)
  • Dyspnea(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javad Kojuri

Professor

Shiraz University of Medical Sciences

研究点 (2)

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