Coronary Arterial Disease (CAD)NCT06702748
Prognostic Values of Coronary Microvascular Dysfunction Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention
An observational study of Coronary Arterial Disease (CAD) and Coronary Microvascular Dysfunction (CMD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Coronary Microvascular Dysfunction (CMD)
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI
Who may be able to join
- Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI
Who cannot join
- target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on New Technologies for the Diagnosis and Treatment of Cardiovascular Diseases-Multi-parameter Noninvasive Early Diagnosis of Coronary Microvascular Diseases Series I: Clinical Study Protocol for a New Method of Evaluating Coronary Microvessels Based on Coronary IMR Calculated from Coronary Angiography Images
The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.
The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.
Participants will answer survey questions about their clinical outcomes for 2 years by telephone.
Read the detailed description
This study was a retrospective, multicenter observational investigation and approved by the local Human Research Ethics Committee and conducted in accordance with the principles outlined in the Helsinki Declaration.Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI were eligible for inclusion in the study. Exclusion criteria included target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification.
Angiography-derived index of microcirculatory resistance was measured in the target vessel treated with RA pre-PCI and post-PCI and blinded and performed by an independent core laboratory.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.
- Keywords
- Coronary Microvascular Dysfunction, Index of Microcirculatory Resistance, Coronary artery disease, rotational atherectomy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary microvascular dysfunction | angio-IMR>=25 | |
| Non-Coronary microvascular dysfunction | Angio-IMR<25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events
the composite of cardiac death, myocardial reinfarction, target vessel revascularization, and readmission for unstable angina
Measured: 24 months after PCI
Secondary outcomes (1)
target vessel failure
composed of cardiac death, target vessel myocardial infarction, target vessel revascularization
Measured: 24 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Jan 2015
- Primary completion31 Oct 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702748
- Sponsor's protocol ID
- 20220940-3
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Feng L, Zhang Y, Zhang C, Chen Z, Pan J, Gao Z, Chen D, Yidilisi A, Fang J, Zheng Y, Mei T, Liu J, Xiang J, Zhang J, Li C, Cheng J, Wang J, Jiang J. Prognostic impact of type 2 diabetes mellitus and coronary microvascular dysfunction in patients undergoing rotational atherectomy during PCI. Cardiovasc Diabetol. 2025 Jul 24;24(1):298. doi: 10.1186/s12933-025-02868-5.
PubMed 40707926
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on New Technologies for the Diagnosis and Treatment of Cardiovascular Diseases-Multi-parameter Noninvasive Early Diagnosis of Coronary Microvascular Diseases Series I: Clinical Study Protocol for a New Method of Evaluating Coronary Microvessels Based on Coronary IMR Calculated from Coronary Angiography Images
- ClinicalTrials.gov ID
- NCT06702748
- Acronym / sponsor ID
- 20220940-3
- Keywords
- Coronary Microvascular Dysfunction, Index of Microcirculatory Resistance, Coronary artery disease, rotational atherectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.
The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.
Participants will answer survey questions about their clinical outcomes for 2 years by telephone.
Detailed description
This study was a retrospective, multicenter observational investigation and approved by the local Human Research Ethics Committee and conducted in accordance with the principles outlined in the Helsinki Declaration.Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI were eligible for inclusion in the study. Exclusion criteria included target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification.
Angiography-derived index of microcirculatory resistance was measured in the target vessel treated with RA pre-PCI and post-PCI and blinded and performed by an independent core laboratory.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary microvascular dysfunction | – | –angio-IMR>=25 |
| Non-Coronary microvascular dysfunction | – | –Angio-IMR<25 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI
Key inclusion criteria (1 listed)
- Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI
Key exclusion criteria (1 listed)
- target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major adverse cardiac events
Time frame: 24 months after PCI
the composite of cardiac death, myocardial reinfarction, target vessel revascularization, and readmission for unstable angina
1 secondary outcome
target vessel failure
Time frame: 24 months after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 40707926Feng L, Zhang Y, Zhang C, Chen Z, Pan J, Gao Z, Chen D, Yidilisi A, Fang J, Zheng Y, Mei T, Liu J, Xiang J, Zhang J, Li C, Cheng J, Wang J, Jiang J. Prognostic impact of type 2 diabetes mellitus and coronary microvascular dysfunction in patients undergoing rotational atherectomy during PCI. Cardiovasc Diabetol. 2025 Jul 24;24(1):298. doi: 10.1186/s12933-025-02868-5.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Coronary Microvascular Dysfunction (CMD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac events (time frame: 24 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06702748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.