Coronary Artery DiseaseREC-CHARTENDSNCT07378137
Comparing the Components of Composite Endpoints for Healthcare Providers and Patients
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Xijing Hospital at 1 site in China.
Trial summary
Clinical trials often employ a composite primary endpoint to increase event rates and enhance trial efficiency. However, analytic approaches to composite endpoints typically assume that the individual components are of similar importance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- Questionnaire
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Healthcare providers and patients with CAD
Who may be able to join
- Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
- Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
- Healthcare providers who treat patients with coronary artery disease.
Who cannot join
- Aged < 18 years;
- Inability to understand the questionnaire or presence of cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Shutong Li, MBBS, 13379338216, shutongli@fmmu.edu.cn
About this study
Official title: A Preference Study Comparing the Components of Composite Endpoints for Healthcare Providers and Patients With CAD
Clinical trials often employ a composite primary endpoint to increase event rates and enhance trial efficiency. However, analytic approaches to composite endpoints typically assume that the individual components are of similar importance. In practice, a treatment often has different effects on each individual endpoint, leading to uncertainty in interpreting the results of a clinical trial employing a composite primary endpoint.
Some investigators have recommended using a weighted composite endpoint to address these concerns, in which individual components are valued relative to one another. However, data to inform the weighting of individual endpoints, using opinions from both medical staff and patients, remains controversial. Furthermore, prior efforts to weigh composite endpoints have assumed that patients, physicians, and clinical trialists would assign similar values to individual events. If patients value endpoints differently from trialists, this would suggest that efforts to develop weighted composite endpoints may also need to address patient preferences.
In the current study, we aim to record the weighing of both patients and medical staff towards a composite endpoint frequently used in cardiovascular clinical trials. To better understand the value of each endpoint for patients and medical staff, we quantified the relative severity of each endpoint when compared to death and assessed for rating differences between the two groups. Additionally, we investigated whether endpoint weights varied by the demographic and clinical characteristics of patients and medical staff.
- Being tested
- Questionnaire
- Keywords
- coronary artery disease, composite endpoints
- 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.
QuestionnaireOther
A questionnaire regarding the weights given by the patients with CAD and the medical staff for the individual components of the composite endpoint
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Medical staff and patients with CAD Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative weight of myocardial infarction to death
Measured: Before discharge
Relative weight of stroke to death
Measured: Before discharge
Relative weight of cardiopulmonary resuscitation to death
Measured: Before discharge
Relative weight of procedural complications to death
Measured: Before discharge
Relative weight of major bleeding events to death
Measured: Before discharge
Relative weight of acute kidney injury to death
Measured: Before discharge
Relative weight of revascularization to death
Measured: Before discharge
Relative weight of rehospitalization to death
Measured: Before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start18 Aug 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, M.D., Ph.D, Study chair, Xijing HospitalChao Gao, M.D., Ph.D, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378137
- Sponsor's protocol ID
- REC-CHARTENDS
- Acronym
- REC-CHARTENDS
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preference Study Comparing the Components of Composite Endpoints for Healthcare Providers and Patients With CAD
- ClinicalTrials.gov ID
- NCT07378137
- Acronym / sponsor ID
- REC-CHARTENDS / REC-CHARTENDS
- Keywords
- coronary artery disease, composite endpoints
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
Clinical trials often employ a composite primary endpoint to increase event rates and enhance trial efficiency. However, analytic approaches to composite endpoints typically assume that the individual components are of similar importance. In practice, a treatment often has different effects on each individual endpoint, leading to uncertainty in interpreting the results of a clinical trial employing a composite primary endpoint.
Some investigators have recommended using a weighted composite endpoint to address these concerns, in which individual components are valued relative to one another. However, data to inform the weighting of individual endpoints, using opinions from both medical staff and patients, remains controversial. Furthermore, prior efforts to weigh composite endpoints have assumed that patients, physicians, and clinical trialists would assign similar values to individual events. If patients value endpoints differently from trialists, this would suggest that efforts to develop weighted composite endpoints may also need to address patient preferences.
In the current study, we aim to record the weighing of both patients and medical staff towards a composite endpoint frequently used in cardiovascular clinical trials. To better understand the value of each endpoint for patients and medical staff, we quantified the relative severity of each endpoint when compared to death and assessed for rating differences between the two groups. Additionally, we investigated whether endpoint weights varied by the demographic and clinical characteristics of patients and medical staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Other: QuestionnaireMedical staff and patients with CAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare providers and patients with CAD
Key inclusion criteria (3 listed)
- Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
- Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
- Healthcare providers who treat patients with coronary artery disease.
Key exclusion criteria (2 listed)
- Aged < 18 years;
- Inability to understand the questionnaire or presence of cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA questionnaire regarding the weights given by the patients with CAD and the medical staff for the individual components of the composite endpoint | Other | Subjects |
Primary outcome
Relative weight of myocardial infarction to death
Time frame: Before discharge
Relative weight of stroke to death
Time frame: Before discharge
Relative weight of cardiopulmonary resuscitation to death
Time frame: Before discharge
Relative weight of procedural complications to death
Time frame: Before discharge
Relative weight of major bleeding events to death
Time frame: Before discharge
Relative weight of acute kidney injury to death
Time frame: Before discharge
Relative weight of revascularization to death
Time frame: Before discharge
Relative weight of rehospitalization to death
Time frame: Before discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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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.
Ling Tao, M.D., Ph.D study chair
Xijing Hospital
Chao Gao, M.D., Ph.D study chair
Xijing Hospital
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 Artery Disease and Percutaneous Coronary Intervention, run by Xijing Hospital 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruining Zhang, BSc (86-15802990370, ruining-zhang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative weight of myocardial infarction to death (time frame: Before discharge). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.