NCT00387231

Brief Summary

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy on long-term outcome in patients with recent myocardial infarction and silent ischemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1991

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1991

Completed
14.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
Last Updated

October 12, 2006

Status Verified

October 1, 2006

First QC Date

October 10, 2006

Last Update Submit

October 10, 2006

Conditions

Keywords

Myocardial IschemiaRandomized Controlled TrialsAngioplasty, Transluminal, Percutaneous CoronaryDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization

Secondary Outcomes (1)

  • Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recent myocardial infarction within last 3 months
  • Documented silent myocardial ischemia (type I)

You may not qualify if:

  • Symptomatic myocardial ischemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Hospital Lucerne

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (2)

  • Schoenenberger AW, Jamshidi P, Kobza R, Zuber M, Stuck AE, Pfisterer M, Erne P. Progression of coronary artery disease during long-term follow-up of the Swiss Interventional Study on Silent Ischemia Type II (SWISSI II). Clin Cardiol. 2010 May;33(5):289-95. doi: 10.1002/clc.20775.

  • Erne P, Schoenenberger AW, Burckhardt D, Zuber M, Kiowski W, Buser PT, Dubach P, Resink TJ, Pfisterer M. Effects of percutaneous coronary interventions in silent ischemia after myocardial infarction: the SWISSI II randomized controlled trial. JAMA. 2007 May 9;297(18):1985-91. doi: 10.1001/jama.297.18.1985.

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Paul Erne, MD

    Department of Cardiology, Hospital Lucerne

    STUDY CHAIR
  • Paul Erne, MD

    Department of Cardiology, Hospital Lucerne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

June 1, 1991

Study Completion

May 1, 2006

Last Updated

October 12, 2006

Record last verified: 2006-10

Locations