Study of the effectiveness of Diltiazem on symptoms in patients with slow flow coronary angiography during a 6-month follow-up; A randomized clinical trial

Determining the effect of diltiazem on clinical symptoms of patients with coronary slow flow phenomenon

A controlled, parallel-group, unblinded, randomized, phase 3 clinical trial on 80 patients.

80 patients referred for diagnostic angiography to Shariati Hospital in 1404 will be randomly divided into 2 groups of 40 (intervention and control). Oral diltiazem at a dose of 60 mg every 12 hours will be given, and the other group will be given conventional medications. After 6 months, changes in clinical symptoms of the patients in the two groups will be evaluated by a specialist physician in the clinic.

Inclusion criteria: Diagnostic angiography due to chronic symptoms or a positive non-invasive stress test, in which the contrast agent has not yet reached the end of the coronary arteries despite 3 heartbeats during angiography, or the patient has a TIMI frame count greater than 27 during angiography. No history of MI or prior revascularization Exclusion criteria: Cardiomyopathy with an ejection fraction below 40%. History of allergy to diltiazem Systolic blood pressure less than or equal to 90 mmHg Moderate or severe valvular heart disease Congenital heart disease Coronary artery stenosis of more than 50% or coronary artery ectasia Bradycardia with a heart rate below 60 Angina pectoris with NYHA classification 3 and 4 2nd and 3rd degree atrioventricular block

In the intervention group, in addition to common medications, they received oral diltiazem at a dose of 60 mg every 12 hours for six months, and in the control group, they received only common medications and were followed up for six months.

Changes in patients' clinical symptoms, including chest pain, functional chest pain, and functional shortness of breath, 6-minute walking test

Patients will be divided into two groups of 40 members using block randomization, one group will receive diltiazem 60 mg twice daily (D) in addition to conventional medications, and the other group will receive conventional medications only (N). Randomization will be performed in blocks of 4. There will be six different control and treatment group conditions for the blocks of 4: 1.DDNN 2.DNDN 3.DNND 4.NNDD 5.NDND 6.NDDN We will generate random numbers with the help of a computer. For numbers between 0 and 1/6 of combination 1 (DDNN), numbers between 1/6 and 2/6 of combination 2 (DNDN), numbers between 2/6 and 3/6 of combination 3 (DNND), numbers between 3/6 and 4/6 of combination 4 (NNDD), numbers between 4/6 and 5/6 of combination 5 (NDND), and numbers between 5/6 and 6/6 of combination 6 (NDDN).