Efficacy and Safety of Comprehensive Treatment in Patients with Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Self-controlled Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Behavioral
Study Type: Observational
SUMMARY

This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Fulfilling all the following criteria before initiation of comprehensive treatment:

‣ 1 18 years of age or older, male or female.

‣ 2 Negative result of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).

‣ 3 Prior history of coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]).

‣ 4 Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease (AS-CAD) after the last coronary revascularization.

‣ 5 Hospitalization due to rapidly-progressive myocardial ischemia:

⁃ Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and

⁃ Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.

‣ 6 Angiographic evidence of new coronary lesions (de novo stenoses or restenoses):

⁃ Occurred after the last coronary revascularization; and

⁃ Related to myocardial ischemia (location, extent, severity, et al).

‣ 7 Evidence of inflammation:

⁃ At least one of the markers indicating active inflammation has ever been elevated (erythrocyte sedimentation rate \[ESR\], high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or

⁃ Established diagnosis of systemic autoimmune disease or systemic vasculitis; or

⁃ Receiving immunosuppressive therapy.

• Receiving comprehensive treatment, including ischemia-driven PCI which was performed no earlier than 40 days of the initiation of immunosuppressive therapy.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhenyu Liu, M.D.
Pumch_lzy@163.com
+861069155068
Time Frame
Start Date: 2023-05-17
Estimated Completion Date: 2025-09
Participants
Target number of participants: 39
Treatments
Pre-treatment Group
IR-CAD patients before receiving comprehensive treatment.
Post-treatment Group
IR-CAD patients after receiving comprehensive treatment.
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov