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Percutaneous coronary intervention versus conservative treatment in patients with stable angina pectoris (EUREGIO AP study): Can magnetic resonance perfusion imaging improve the triage of patients with stable angina?

Percutaneous coronary intervention versus conservative treatment in patients with stable angina pectoris (EUREGIO AP study): Can magnetic resonance perfusion imaging improve the triage of patients with stable angina? - EUREGIO-AP-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34978
Enrollment
400
Registered
2010-01-15
Start date
2010-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Atherosclerosis

Interventions

Patients with major ischemia in the *treatment with knowledge of MRI results*- group will undergo PCI according to standard technique. The cardiologist will insert a sheath into the femoral artery (o

Sponsors

Cardiologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients with stable angina pectoris and >=70% stenosis in at least one epicardial coronary artery (proximal or mid segment) can be included. Stable angina pectoris is defined as Canadian Cardiovascular Society [CCS] class I-III or medically stabilized class IV angina. Patients must be able to give informed consent.

Exclusion criteria

Exclusion criteria: General: - Age 200/100mmHg) unresponsive to medical therapy.;Other cardiac pathology: - Atrial fibrillation. - Cardiogenic shock. - Previous myocardial infarction, defined as: (UNL = upper normal limit) a) New Q wave at any time. b) Spontaneous, total CK/CK-MB >= 1.5 x UNL or troponin >= 2 x UNL. - Congestive heart failure NYHA class >=III. - Previous CABG or PCI. - Unstable angina pectoris (persistent CCS class IV despite medical treatment). - Left main (>= 50%) or 3 vessel disease or markedly positive treadmill test during stage 1 of the Bruce protocol. - Ejection fraction 130 kg. ;Contraindication to MRI contrastagent (Gadolinium): - Renal failure (estimated GFR =70% stenosis).

Design outcomes

Primary

MeasureTime frame
The primary study parameters are a combined endpoint of time to adverse cardiac events defined as: all-cause mortality, myocardial infarction/acute coronary syndrome, hospitalization for unstable angina with negative biomarkers, coronary artery bypass grafting and coronary angioplasty.

Secondary

MeasureTime frame
The secondary end points are quality of life (Canadian Cardiovascular Society angina class at follow-up); the usage of antianginal drugs, cost-effectiveness and the prognostic value of hs-cTNT.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)