Due to the limited access to patient database and non-cooperation in referral of patients after receiving the codeس of ethics and IRCT , after several months to June 2019 and the possibility of easier access to patients' angiography database in Sina Hospital, with the guidance of professors and counselors and council Graduate studies of the faculty, the jury, and Sinai Hospital were added as another center for morbidity, and the angiography database of Sinai Hospital (2016-2017) was used.
According to the project's cardiologist, all patients with X-ray heart syndrome should still be treated with diltiazem + atorvastatin for one month, despite previous use of the drug, before entering the study, and if they do not recover after one month.In the period from 2019/5/28 to 2019/9/6 from a 200-person database (2016-2017) of patients with normal angiography and positive ETT , by screening other inclusion and exclusion criteria, only 25 patients had drug resistant angina pain , 17 of the 25 patients had other criteria for entering the study. According to the cardiologist of the project, despite the use of other anti- ischemic in patients, all patients were treated with diltiazem + estrostatin for one month, and if they did not improve later. Within a month, they study were enrolled in the study. seven people were still in pain after a month. then they were enrolled and randomized, after two months follow-up, the study continued with only four people. In the first progress report, due to the lack of sample size required to conduct a study of a 204-person database of patients with normal angiography and positive exercise testing, according to supervisors, counselors and methodologists, the study was conducted as a single group. Let's continue, and the range of common medications prescribed for patients with cardiac syndrome X is a variety of anti-ischemics (calcium blocker, beta-blocker, nitrate) and medications such as ACE inhibitor, atorvastatin, so for enrolling the patients with drug resistant cardiac syndrome X , instead of prescribing diltiazem and atorvastatin to all patients despite the use of other drugs in the spectrum, Documented drug resistant cardiac syndrome X (persistent chest pain for at least 6 months, despite the use of a maximum dose of a combination of two ischemic compounds (calcium blocker, beta-blocker, nitrate) or a combination of one anti- ischemic and one Alternative drugs such as ACE inhibitor, estrostatin) are approved by the design consultant cardiologist, and the syrup of study is added to conventional drugs in the same way.
The study was considered as a pilot in the period of 2019/5/28 to 2019/9/6 ,and based on the analysis of patient response rate, and considering the safety of the drug, it was decided to increase at least dose of of syrup as 5 cc BID to twice as much as 10 cc BID.