Thresholds of invasive physiological indices associated with angina and limited exercise capacity in patients with chronic coronary syndrome

Thresholds of invasive physiological indices associated with angina and limited exercise capacity in patients with chronic coronary syndrome - SYMPTOM REGISTRY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048065

Enrollment

200

Registered

2022-06-15

Start date

2022-06-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

chronic coronary syndrome

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20 years or older at the time of consent acquisition 2. Patients who understand the contents of informed consent by the investigators and sign the consent form written by himself / herself. 3. Patients with chronic coronary syndrome who are judged by the investigators to be indicated for coronary angiography

Exclusion criteria

Exclusion criteria: 1. Patients with left ventricular ejection fraction less than 35% 2. Patients who have a history of coronary artery bypass grafting 3. Patients with unstable hemodynamics 4. Patients with heart failure of NYHA classification III or IV 5. Patients with a limitation in walking due to diseases other than chronic coronary syndrome 6. Patients with severe valvular heart disease 7. Patients on maintenance dialysis 8. Patients with unstable angina and acute myocardial infarction within 1 month

Design outcomes

Primary

Measure	Time frame
1) The thresholds of FFR and dPR associated with angina 2) The thresholds of FFR and dPR associated with limited exercise capacity during 6-minute walk test 3) The thresholds of FFR and dPR after PCI associated with the improvement of angina 4) The thresholds of FFR and dPR after PCI associated with the improvement of exercise capacity 5) The thresholds of the gains of FFR and dPR between pre and post PCI associated with the improvement of angina 6) The thresholds of the gains of FFR and dPR between pre and post PCI associated with the improvement of exercise capacity	—

Measure

Time frame

1) The thresholds of FFR and dPR associated with angina 2) The thresholds of FFR and dPR associated with limited exercise capacity during 6-minute walk test 3) The thresholds of FFR and dPR after PCI associated with the improvement of angina 4) The thresholds of FFR and dPR after PCI associated with the improvement of exercise capacity 5) The thresholds of the gains of FFR and dPR between pre and post PCI associated with the improvement of angina 6) The thresholds of the gains of FFR and dPR between pre and post PCI associated with the improvement of exercise capacity

—

Secondary

Measure	Time frame
1) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without ischemia 2) RDS score and SAQ score between patients with and without ischemia 3) RDS score and SAQ score between patients with and without angina during 6-minute walk 4) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without ischemia after PCI 5) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without significant gains of FFR and dPR after PCI 6) Pre and post-test comparison of the distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk in patients who did not undergo PCI 7) RDS score and SAQ score between patients with and without ischemia after PCI 8) The pre and post-PCI comparison of RDS score and SAQ score between patients with and without ischemia after PCI. 9) RDS score and SAQ score between patients with and without significant gains of FFR and dPR after PCI 10) The pre and post-PCI comparison ofRDS score and SAQ score between patients with and without significant gains of FFR and dPR after PCI 11) The pre and post-test comparison of RDS score and SAQ score in patients who did not undergo PCI 12) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and ejection fraction (EF) between patients with and without ischemia 13) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and EF between patients with and without angina during 6-minute walk 14) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and EF between patients with and without limited walk distance during 6-minute walk	—

Measure

Time frame

1) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without ischemia 2) RDS score and SAQ score between patients with and without ischemia 3) RDS score and SAQ score between patients with and without angina during 6-minute walk 4) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without ischemia after PCI 5) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without significant gains of FFR and dPR after PCI 6) Pre and post-test comparison of the distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk in patients who did not undergo PCI 7) RDS score and SAQ score between patients with and without ischemia after PCI 8) The pre and post-PCI comparison of RDS score and SAQ score between patients with and without ischemia after PCI. 9) RDS score and SAQ score between patients with and without significant gains of FFR and dPR after PCI 10) The pre and post-PCI comparison ofRDS score and SAQ score between patients with and without significant gains of FFR and dPR after PCI 11) The pre and post-test comparison of RDS score and SAQ score in patients who did not undergo PCI 12) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and ejection fraction (EF) between patients with and without ischemia 13) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and EF between patients with and without angina during 6-minute walk 14) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and EF between patients with and without limited walk distance during 6-minute walk

—

Countries

Japan

Contacts

Public ContactDaisuke HIgashioka

Wakayama Medical University Department of Cardiovascular Medicine

higashio@wakayama-med.ac.jp073-447-2300

Outcome results