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A prospective, self-controlled, multicenter clinical trial evaluating the efficacy and safety of cardiac coronary blood supply function assessment software for functional diagnosis of coronary stenosis and coronary microcirculation

A prospective, self-controlled, multicenter clinical trial evaluating the efficacy and safety of cardiac coronary blood supply function assessment software for functional diagnosis of coronary stenosis and coronary microcirculation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055187
Enrollment
Unknown
Registered
2022-01-02
Start date
2021-12-27
Completion date
Unknown
Last updated
2023-01-16

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

Conditions

coronary heart disease

Interventions

Gold Standard:FFR value and IMR value measured by pressure guide wire
Index test:DSA image

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. To be diagnosed or diagnosed with coronary heart disease, coronary angiography is required; 3. Understand the purpose of the trial, participate voluntarily, and sign the informed consent; 4. The reference lumen diameter of the stenotic segment of the coronary angiography is >=2mm; 5. Coronary angiography showed at least one stenosis of 30% to 90%.

Exclusion criteria

Exclusion criteria: 1. The target vessel has coronary artery bypass surgery in the past; 2. Myocardial infarction within 30 days before surgery; 3. NYHA cardiac function grade >= grade III; 4. Those with other severe diseases who are not suitable for clinical trials, such as severe arrhythmia or tachycardia, sick sinus syndrome, severe asthma, severe or very severe chronic obstructive pulmonary disease; 5. Serum creatinine > 150 µmol/L; 6. Allergy to iodine-containing contrast agents; 7. Pregnant patients; 8. Participating in other clinical trials and not yet out of the group; 9. The investigator determines that it is not suitable for diagnostic interventional operations or FFR testing, or is considered unsuitable for enrollment for other reasons; 10. There is myocardial bridge in the target lesion; 11. The target lesion involves the left main trunk or the opening of the right coronary within 3mm (stenosis>50%); 12. Low-quality angiography with poor contrast agent filling or inability to detect vessel boundaries due to various reasons, overlapping vessels or severe distortion of target vessels cannot fully expose the lesion location, and it is expected that the calculation cannot be performed.

Design outcomes

Primary

MeasureTime frame
FFR;IMR;accuracy;positive predictive value;negative predictive value;

Countries

China

Contacts

Public ContactZeng Yong

Beijing Anzhen Hospital Affiliated to Capital Medical University

13501373114@163.com+86 13501373114

Outcome results

None listed

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