International Study of comparative health effectiveness with medical and invasive approaches

International Study of comparative health effectiveness with medical and invasive approaches - Ischemia trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41604

Enrollment

Registered

2014-03-13

Start date

2015-01-20

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronairy heartdisease stable ischemic heart disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Informed Consent Ischemia Eligible for CT

Exclusion criteria

Exclusion criteria: LVEF

Design outcomes

Primary

Measure	Time frame
The primary aim of the ISCHEMIA trial is to determine whether an invasive strategy of routine early catheterization followed by optimal revascularization, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for refractory angina symptoms, acute coronary syndrome, acute ischemic heart failure, or resuscitated cardiac arrest	—

Measure

Time frame

The primary aim of the ISCHEMIA trial is to determine whether an invasive strategy of routine early catheterization followed by optimal revascularization, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for refractory angina symptoms, acute coronary syndrome, acute ischemic heart failure, or resuscitated cardiac arrest

—

Secondary

Measure	Time frame
The secondary aims are to compare the following clinical and economic outcomes in participants randomized to INV or CON strategies: Angina control, Quality of Life, Hospitalization for unstable angina, Hospitalization for heart failure, stroke, costs, and cost-effectiveness	—

Countries

Netherlands

Outcome results