NCT07613996Recruiting
Impact of Hyperemic State on Angio-IMR Performance
The Impact of Hyperemic State on the Performance of Angiography Derived Indices in Assessing Coronary Microvascular Disease
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
The goal of this observational study is to evaluate the diagnostic performance of angiography-derived microcirculatory indices (Angio-IMR) in assessing patients with stable angina or suspected coronary artery disease. The main questions it aims to answer are: How do the numerical values of Angio-IMR from five different software vendors change across three physiological states (resting, sub-hyperemia induced by nitroglycerin, and maximal hyperemia induced by adenosine)? Which physiological state and software algorithm provide the highest diagnostic accuracy (Area Under the Curve, AUC) for diagnosing Coronary Microvascular Disease (CMD) when compared to the gold standard wire-based IMR? Researchers will compare the Angio-IMR results calculated under the three different physiological conditions within the same patient to see how the hyperemic state impacts the performance and consistency of these non-invasive indices. Participants will: Undergo standard-of-care coronary angiography and physiological assessment using a pressure wire for index of microvascular resistance (Wire-IMR) as part of their clinical management. Have their angiographic images captured at three specific time points: at rest, after intracoronary nitroglycerin, and during adenosine-induced maximal hyperemia. Allow their de-identified imaging and clinical data to be analyzed by an independent core laboratory using five different Angio-IMR software platforms to evaluate microvascular function.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 192 (estimated)
- First submitted
- 11 May 2026
- Start date
- 4 May 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07613996
What you commit to
- Study type: Observational
- Planned participants: 192
- From 4 May 2026 to the primary completion date, 31 Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hemodynamic instability (acute myocardial infarction, cardiogenic shock, severe arrhythmia).
- Contraindications to angiography (e.g., end-stage renal disease).
Other
- Contraindications to adenosine (e.g., severe asthma, high-degree atrial-ventricular block).
- Life expectancy \< 1 year or pregnancy.
- Target vessel unsuitable for wire operation (left main lesion, severe tortuosity) or stenosis \> 90%.
Who the study is looking for
- Stable angina or suspected coronary heart disease.
- Scheduled for coronary angiography and physiological assessment.
- Target vessel with stenosis \< 50% or 50%-90% with fractional flow reserve (FFR) \> 0.80.
- Provided informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.