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Study on the consistency of caIMR and IMR in evaluating coronary microvascular dysfunction

Prospective, multicenter, non inferiority study of evaluation caIMR compared with IMR in evaluating coronary microvascular dysfunction

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036510
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-08-31
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic coronary syndrome

Interventions

Sponsors

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Subject is over 18 years old, under 70 years old (including 70 years old), and gender is not limited; 2. Patients with chronic coronary syndrome who meet the diagnostic criteria of the 2019 European Society of Cardiology 'Guidelines for the Diagnosis and Management of Chronic Coronary Syndrome', including: (1) patients with suspected CAD and 'stable' anginal symptoms, and/or dyspnea; (2) patients with new onset of heart failure or left ventricular dysfunction and suspected CAD; (3) asymptomatic and symptomatic patients with stabilized symptoms 1 year after initial diagnosis or revascularization; (5) patients with angina and suspected vasospastic or microvascular disease; and (6) asymptomatic subjects in whom CAD is detected at screening. 3. The subjects coronary angiography image meets the following manifestations: the degree of stenosis of the coronary lumen diameter is less than 70%; 4. The subject voluntarily participates in this clinical trial and signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. The subject is diagnosed with heart failure with reduced ejection fraction; 2. Target blood vessel of subject has undergone revascularization within 3 months; 3. The subject has received an organ transplant, or is waiting to receive an organ transplant. 4. The subject is receiving or planning to receive chemotherapy within 30 days before and after the operation; 5. The subject is intolerant to iodine contrast agent, adenosine or adenosine triphosphate; 6. The subject may have a serious disease that reduces the life expectancy to less than 24 months; 7. The subject has drug abuse problems (such as alcohol, cocaine, heroin, etc.); 8. The subject's complete blood count is outside the range, and the investigator confirms that it has clinical significance, or patients with moderate or higher anemia; 9. The subject has clear or suspicious liver disease, including laboratory evidence of hepatitis; 10. The subject is undergoing dialysis or the baseline serum creatinine level is >2.5 mg/dL (221µmol/L); 11. The subject has a bleeding tendency or a history of coagulopathy; 12. The subject has active gastric ulcer or active gastrointestinal bleeding; 13. The subject is participating in a clinical study of drug or medical device and has not reached its endpoint; 14. The subject is pregnant or breast-feeding.(Women of childbearing age must undergo a pregnancy checkup within 7 days before the operation); 15. Subject has endocrine diseases including hypothyroidism/hyperthyroidism diseases; 16. The results of coronary angiography suggest the following conditions: (1) The target coronary artery involves coronary artery fistula and myocardial bridge; (2) The contrast agent of the target blood vessel in the coronary angiography image is not filled, or overlapped, or severely distorted, lead to the lesion location not be fully exposed; or image quality is too poor to be clearly identified; (3) The stenosis degree of the left main coronary artery lesion is not less than 50%; (4) Investigator believes that subjects cannot tolerate IMR test; (5) The subject's coronary artery requires interventional treatment.

Design outcomes

Primary

MeasureTime frame
IMR;coronary angiography index of Diastolic Microcirculatory Resistance;

Countries

China

Contacts

Public ContactXian Wang/ Wenhua Peng

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

pengwenhua76@163.com+86 13901291371/ +86 13810856080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026