Skip to content

INTERNATIONAL STUDY OF COMPARATIVE HEALTH EFFECTIVENESS WITH MEDICAL AND INVASIVE APPROACHES. ISCHEMIA.

INTERNATIONAL STUDY OF COMPARATIVE HEALTH EFFECTIVENESS WITH MEDICAL AND INVASIVE APPROACHES. ISCHEMIA.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-012-14
Enrollment
80
Registered
2014-05-22
Start date
2014-02-28
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Conservative (CON) Strategy In participants randomized to the CON strategy, initial management with OMT alone will be employed (described below). A fundamental principle of the CON strategy is to

Sponsors

National Heart, Lung, and Blood Institute,
Lead Sponsor

Eligibility

Age
21 Years to 99 Years

Inclusion criteria

Inclusion criteria: At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (≥10% myocardium), echo or cardiac magnetic resonance wall motion (≥3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac magnetic resonance perfusion (≥12% myocardium). Participant is willing to comply with all aspects of the protocol, including adherence to medical therapy and follow-up visits. Participant is willing to give written informed consent. Age ≥ 21 years

Exclusion criteria

Exclusion criteria: LVEF 50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available). Finding of “no obstructive CAD” (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months Prior known coronary anatomy unsuitable for either PCI or CABG Unacceptable level of angina despite maximal medical therapy Very dissatisfied with medical management of angina History of noncompliance with medical therapy Acute coronary syndrome within the previous 2 months PCI or CABG within the previous 12 months Stroke within the previous 6 months or intracranial hemorrhage at any time History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months Non-ischemic dilated or hypertrophic cardiomyopathy End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min. (Please, check the 5.3 Protocol section).

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Hungary, India, Israel, Italy, Japan, Korea North, Korea South, Lithuania, Macedonia, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Spain, Switzerland, Thailand, United Kindgdom, United States

Contacts

Public ContactWalter Enrique Mogrovejo

Instituto Neuro Cardiovascular de las Americas (INCA)

investigacion@inca.org.pe610 6666 anexo 610

Outcome results

None listed

Source: REPEC (via WHO ICTRP)