Coronary Heart DiseasePCICODENCT03852082
Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention
An observational study of Coronary Heart Disease and Percutaneous Coronary Intervention, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention, Depression
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 2,600 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2019to 30 Dec 2026
- How long will I take part?
- 24 Months
- 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: Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention
Who may be able to join
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years or older；
- Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA；
- Willingness to participate in the follow-up study for at least 1 year.
Who cannot join
- Inability to provide written informed consent;
- Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse);
- Tendency of suicide;
- Pregnant or lactating women;
- Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements;
- Any other reasons that investigators based on professional judgments that would place the patient at increased risk.
- Patient with STEMI within 24-hour from the onset of chest pain to admission.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.
Read the detailed description
Coronary heart disease (CHD) is a clinical relevant psychosomatic issue. Treatment strategies include percutaneous coronary intervention (PCI), guidelines medication (GDMT) and coronary artery bypass grafting (CABG) were clinical proven to be effective to realize myocardial revascularization post CHD. Previous studies revealed that diagnosed depressed CHD patients have 3.6 times higher risk of major adverse events (MACE) post percutaneous coronary intervention than nondepressed. However, a reliable explanation of how depression impact clinical outcomes of CHD patients post PCI is lacking. The objective of this study is to observe the incidence of major adverse cardiovascular events in patients with coronary heart disease co-morbid with depression post PCI, and to explore a prognostic model of clinical outcomes based on physiological, interventional, socio-economic and psychological factors among these patients.
- Being tested
- percutaneous coronary intervention
- Medical subject headings
- Coronary Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Major Adverse Events
major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.
Measured: 36-month
Secondary outcomes (5)
Number of Participants with All-cause Mortality
Measured: 36-month
Number of Participants with Cardiovascular Mortality
Measured: 36-month
Number of Participants with Myocardial Infarction
Measured: 36-month
Number of Participants with In-Stent Thrombosis
Measured: 36-month
Number of Participants with Target-Lesion Revascularization
Measured: 36-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start28 Aug 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 2,600 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shaoliang Chen, phd, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852082
- Sponsor's protocol ID
- 20180317
- Acronym
- PCICODE
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03852082
- Acronym / sponsor ID
- PCICODE / 20180317
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Feb 2019 (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.
A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.
Detailed description
Coronary heart disease (CHD) is a clinical relevant psychosomatic issue. Treatment strategies include percutaneous coronary intervention (PCI), guidelines medication (GDMT) and coronary artery bypass grafting (CABG) were clinical proven to be effective to realize myocardial revascularization post CHD. Previous studies revealed that diagnosed depressed CHD patients have 3.6 times higher risk of major adverse events (MACE) post percutaneous coronary intervention than nondepressed. However, a reliable explanation of how depression impact clinical outcomes of CHD patients post PCI is lacking. The objective of this study is to observe the incidence of major adverse cardiovascular events in patients with coronary heart disease co-morbid with depression post PCI, and to explore a prognostic model of clinical outcomes based on physiological, interventional, socio-economic and psychological factors among these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years or older；
- Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA；
- Willingness to participate in the follow-up study for at least 1 year.
Key exclusion criteria (7 listed)
- Inability to provide written informed consent;
- Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse);
- Tendency of suicide;
- Pregnant or lactating women;
- Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements;
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 |
|---|---|---|
| percutaneous coronary interventionPatients with coronary heart disease co-morbid depression post percutaneous coronary intervention. | Procedure or surgery | – |
Primary outcome
Number of Participants with Major Adverse Events
Time frame: 36-month
major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.
5 secondary outcomes
Number of Participants with All-cause Mortality
Time frame: 36-month
Number of Participants with Cardiovascular Mortality
Time frame: 36-month
Number of Participants with Myocardial Infarction
Time frame: 36-month
Number of Participants with In-Stent Thrombosis
Time frame: 36-month
Number of Participants with Target-Lesion Revascularization
Time frame: 36-month
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Shaoliang Chen, phd study chair
Nanjing First Hospital, Nanjing Medical University
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 Heart Disease and Percutaneous Coronary Intervention, run by Nanjing First Hospital, Nanjing Medical University 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
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?
Number of Participants with Major Adverse Events (time frame: 36-month). 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 13 Apr 2026.