Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction (CPVsSPCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peng Jian Jun, Beijing Shijitan Hospital
ClinicalTrials.gov Identifier:
NCT02154919
First received: May 31, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial


Condition Intervention
Conservative Pharmacotherapy
Staged Percutaneous Coronary Intervention
Non-culprit Vessels
ST-Segment Elevation Myocardial Infarction
Procedure: Percutaneous coronary intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Conservative Pharmacotherapy Versus Staged Percutaneous Coronary Intervention on Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction Patients With Multivessel Disease

Resource links provided by NLM:


Further study details as provided by Beijing Shijitan Hospital:

Primary Outcome Measures:
  • Major Adverse Cardiovascular Events [ Time Frame: 360days ] [ Designated as safety issue: Yes ]

Enrollment: 306
Study Start Date: April 2011
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
complete revascularization group
this group underwent second PCI procedure on the non-culprit vessels and reveived 100-120 IU/kg unfractionated heparin during PPCI, followed by 3 days administration of low molecular weight heparin or Fondaparinux sodium after procedure. Patients in the CP group and CR group after second PCI procedure were given conservative medicine such as Statins which were not contraindicated to the patients.
Procedure: Percutaneous coronary intervention
conservative pharmacotherapy group
patients in conservative group undergoing pharmacotherapy after PPCI. The drugs were the same between two groups.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

STEMI patients after culprit vessels treated by PPCI

Criteria

Inclusion Criteria:

  • age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and ST-segment of electrocardiographic leads between V2 and V3 elevated ≥ 0.2 mV (or ≥ 0.1 mV in ≥ 2 other continuous electrocardiographic leads), cardiac troponin I (cTn I) elevation of > 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, merely underwent PPCI. Additionally, coronary arteriography corroborates lesions in non-culprit vessel (Besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm).

Exclusion Criteria:

  • left main coronary artery disease, cardiogenic shock, complete left bundle branch block (CLBBB) PPCI treated culprit and non-culprit vessels, PPCI failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged PCI, history of PCI or Coronary Artery Bypass Grafting (CABG), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy < 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02154919

Locations
China, Beijing
Beijing Shijitan Hospital
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Beijing Shijitan Hospital
  More Information

No publications provided

Responsible Party: Peng Jian Jun, Beijing Shijitan Hospital, Capital Medical University , Beijing, China, Beijing Shijitan Hospital
ClinicalTrials.gov Identifier: NCT02154919     History of Changes
Other Study ID Numbers: CPVsSPCI
Study First Received: May 31, 2014
Last Updated: May 31, 2014
Health Authority: China: Beijing Municipal Science and Technology Commission

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014