Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort

• Sponsor: Yu Bo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05862103
• Collaborator: (none)
• Enrollment: 15,000
• Locations: 19
• Anticipated Duration (Months): 48.3
• Patients Per Site: 789.5
• Patients Per Site Per Month: 16.3

Study Details

Study Description

Brief Summary

AMI Survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" (project number 2016YFC1301100) and completed the 1-year visit were followed up by telephone at 3 years (within the corresponding follow-up time window) and 5 years after discharge to acquire the patients' medication, health status, and major adverse cardiovascular and cerebrovascular events, including death, heart failure, rehospitalization, re-myocardial infarction, revascularization, stroke, malignant arrhythmia, and bleeding events.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction; Adverse Event	Other: Treatment Strategies

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort - a Prospective, Multicenter Study
• Actual Study Start Date: Dec 20, 2022
• Anticipated Primary Completion Date: Aug 30, 2025
• Anticipated Study Completion Date: Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
optimized group the patients received at least one optimized treatment	Other: Treatment Strategies; AMI emergency treatment process, pre-reperfusion medication, reperfusion strategy selection, and early cardiac rehabilitation after reperfusion
un-optimized group the patients didn't receive optimized treatment

Outcome Measures

Primary Outcome Measures

1. Incidence of MACCE [5 years after discharge]

   the incidence of MACCE (death, heart failure, rehospitalization, re-myocardial infarction, re-myocardial revascularization, stroke, malignant arrhythmia, bleeding events, etc.) in AMI patients

Secondary Outcome Measures

1. Differences of MACCE between the optimized group and the non-optimized group [5 years after discharge]

   Differences of the MACCE between the optimized group and the non-optimized group

2. Differences of the MACCE between OCT-guided group and the coronary angiography -guided group [5 years after discharge]

   Differences of the MACCE between OCT-guided group and the coronary angiography -guided group

3. Differences of MACCE between defer PCI group and direct PCI group [3 and 5 years after discharge]

   Differences of MACCE between defer PCI group and direct PCI group

4. Differences of the MACCE incidence between cardiac rehabilitation quality improvement group and non-cardiac rehabilitation group [5 years after discharge]

   Differences of the MACCE incidence between cardiac rehabilitation quality improvement group and non-cardiac rehabilitation group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• AMI survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" and completed the 1-year visit.

• Telephone to obtain informed consent from the subjects/family members of the subjects.

Exclusion Criteria:

• Not available

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing An Zhen Hospital, Capital Medical University	Beijing	Beijing	China	100029
2	Peking Univerisity People'Hospital	Beijing	Beijing	China	100044
3	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing	China
4	Peking University First Hospital	Beijing	Beijing	China
5	Guangdong general hospital	Guangzhou	Guangdong	China
6	The first affiliated hospital of Guangxi medical university	Nanning	Guangxi	China	530021
7	Second hospital of hebei medical university	Shijiazhuang	Hebei	China
8	Daqing Oil Field Hospital	Daqing	Heilongjiang	China
9	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
10	Zhongda Hospital Southeast University	Nanjing	Jiangsu	China	210009
11	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
12	The Second Hospital of Jilin University	Changchun	Jilin	China	150056
13	The econd Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	China
14	General Hospital of Northern Theater Command of the Chinese People's Liberation Army	Shenyang	Liaoning	China
15	Xijing Hospital of Air Force Military Medical University	Xi'an	Shanxi	China
16	Xinqiao Hospital Army Medical University	Chongqing	Sichuan	China	400000
17	Tianjin Chest Hospital	Tianjing	Tianjin	China
18	The General Hospital of Tianjin Medical University	Tianjin	Tianjin	China
19	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	China

Sponsors and Collaborators

• Yu Bo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yu Bo, Director, Harbin Medical University
• ClinicalTrials.gov Identifier: NCT05862103
• Other Study ID Numbers: KY2022-266
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yu Bo, Director, Harbin Medical University: Acute myocardial infarction; Major adverse cardiac and cerebrovascular event; Optimized treatment
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

No Results Posted as of May 17, 2023