Tongmai Yangxin intervening in myocardial remodeling after PCI for coronary heart disease: study protocol for a double-blind, randomized controlled trial

Table 1 Research flowchart

Item	Research phase
Item	Screening/enrollment	Follow-up
Time	Before enrollment	4 weeks after enrollment	8 weeks after enrollment	12 weeks after enrollment
Time	V0	V1	V2	V3
Confirm inclusion and exclusion criteria	√
Signed informed consent	√
Basic information	√
Medical history, treatment history, and allergies	√
Current medications	√
Retrieve central randomization	√
Efficacy evaluation
Echocardiogram	√	√		√
Cardiac magnetic resonance imaging		√		√
Biological indicator	√	√	√	√
Dynamic electrocardiogram	√	√	√	√
Traditional Chinese medicine syndrome score	√	√	√	√
6-minute walk test	√	√	√	√
Seattle Angina Questionnaire	√	√	√	√
Experiment event rate		√	√	√
Safety
Blood pressure, heart rate, etc.	√	√	√	√
Routine blood and urine parameters	√	√	√	√
Liver and kidney profile	√	√	√	√
Electrolytes	√	√	√	√
Myocardial enzymes	√	√	√	√
Urine pregnancy test	√
Electrocardiogram	√	√	√	√
Appointment for next follow-up		√	√
Study completion status				√
Case report form examination				√

ISSN: 1745-6215