MECP Post martketing Survey

Postmarketing survey for evaluating the safety, efficacy of MECP in refractory angina patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005959

Enrollment

100

Registered

2021-03-05

Start date

2021-03-15

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

None listed

Interventions

Medical Device : MECP compression (30min/day, 1-3 times/week) overall 10 or 35 times

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Angina with CCS class >= II 2) administerd with anti-anginal medication 3) ineligible for further PTCA or CABG

Exclusion criteria

Exclusion criteria: 1. deep vein thrombosis or phlebitis 2. symptomatic or treatable peripheral artery disease 3. moderate or severe valvular heart disease (esp aortic regurgitation) 4. moderate or severe pulmonary hypertension (RVSP >50mmHg) 5. Aortic aneurysm (diameter > 50mm) or cereberal aneurysm 6. uncontrolled hypertension (BP >180/110mmHg) 7. decompensted heart failure 8. arrhythmia intefering MECP function 9. bleeding tendency or severe bleeding history 10. acute infection in leg

Design outcomes

Primary

Measure	Time frame
Angina scale (CCS)	—

Secondary

Measure	Time frame
cardiopulmonary exercise test, 6-minute walking test, central blood pressure, biomarker, frequency of short-acting nitrate administration, frequency of medication change	—

Countries

Korea, Republic of

Contacts

Public ContactWonmi Lee

Yonsei University Health System, Severance Hospital

Outcome results