A multicenter, double-blind, randomized controlled trial on the effect of DLTM Formula on the progression of coronary calcification in patients with stable coronary heart disease

Early Phase 1

Conditions: coronary heart disease,coronary calcification

Registration Number: ITMCTR2024000060

Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Patients definitively diagnosed with coronary heart disease or confirmed by coronary angiography or coronary CT to have coronary artery stenosis =50%, and meet the criteria for stable coronary artery disease;
2) Age between 18 to 75 years, gender unrestricted;
3) Have undergone a 64-slice coronary CT angiography (CTA) within the last 3 months, with the results showing a coronary calcification score between 100 and 2000;
4) Patients voluntarily participate in this trial and sign a written informed consent form.

Exclusion Criteria

1) Patients with other serious cardiac diseases or acute cerebrovascular diseases;
2) Patients with acute or chronic infections, liver or kidney dysfunction, coagulation disorders, thyroid dysfunction, and other severe primary diseases of the immune or hematopoietic systems;
3) Patients with psychiatric diseases or severe neuroses;
4) Participation in another clinical trial within the last month;
5) Patients who have previously undergone coronary artery interventional procedures for calcification;
6) Individuals with allergic constitutions, allergies to known components of the trial medication, or iodine allergies.
7) Pregnant women, those attempting to conceive, or breastfeeding women.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
coronary artery calcification volume score;

Secondary Outcome Measures

Name	Time	Method
Cardiac function indicators, cardiac metabolic risk factors, inflammation-related laboratory indicators, mineral metabolism laboratory indicators, and other hematological indicators;Seattle Angina Questionnaire (SAQ) score;Traditional Chinese Medicine syndrome improvement score/blood stasis syndrome score;Changes in coronary plaque burden;coronary artery Agatston score;Vascular stiffness change;