Clinical trial NCT03852082: Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention
Official title: Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Heart Disease
Percutaneous Coronary Intervention
Depression
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures;
2. Men and women 18 years or older；
3. Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA；
4. Willingness to participate in the follow-up study for at least 1 year.

Exclusion Criteria:

1. Inability to provide written informed consent;
2. Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse);
3. Tendency of suicide;
4. Pregnant or lactating women;
5. Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements;
6. Any other reasons that investigators based on professional judgments that would place the patient at increased risk.
7. Patient with STEMI within 24-hour from the onset of chest pain to admission.

Primary outcomes:
measure: Number of Participants with Major Adverse Events
timeFrame: 12-month
Secondary outcomes:
measure: Number of Participants with All-cause Mortality
timeFrame: 12-month
measure: Number of Participants with Cardiovascular Mortality
timeFrame: 12-month
measure: Number of Participants with Myocardial Infarction
timeFrame: 12-month
measure: Number of Participants with In-Stent Thrombosis
timeFrame: 12-month
measure: Number of Participants with Target-Lesion Revascularization
timeFrame: 12-month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shaoliang Chen, phd
role: STUDY_CHAIR
References: