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A prospective, open-label, single-arm, multi-center study protocol of the diagnostic value of exercise-stress Hyper-QRS ECG in coronary microcirculatory dysfunction diseases

A prospective, open-label, single-arm, multi-center study protocol of the diagnostic value of exercise-stress Hyper-QRS ECG in coronary microcirculatory dysfunction diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101451
Enrollment
Unknown
Registered
2025-04-25
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Coronary Artery Disease

Interventions

Gold Standard:The IMR measured by invasive pressure guidewire is the gold standard for coronary microcirculatory dysfunction
Index test:Exercise stress high-frequency electrocardiogram test

Sponsors

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years old (including critical value), gender is not limited, limbs can be moved, can cooperate with the completion of treadmill experiments; (2) Patients with obvious angina pectoris symptoms and normal troponin suspected coronary heart disease; (3) CMVD should be considered for preoperative diagnosis; (4) Voluntarily participate in the study and sign the informed consent form. (5) Intraoperative coronary angiography was perfected, and the stenosis rate was <50; (6) Stop all drugs that may affect coronary microcirculation (ß-receptor blockers, CCB drugs and proprietary Chinese medicines) three days before receiving exercise stress Hyper-QRS ECG and IMR measurement.

Exclusion criteria

Exclusion criteria: (1) Prior coronary artery bypass grafting; (2) Hospitalized for myocardial infarction or previous history of acute myocardial infarction; (3) cardiogenic shock or the presence of an intra-aortic counterpulsation balloon; (4) Valvular stenosis or heart failure, pericardial disease or non-ischemic cardiomyopathy; (5) Have previous non-cardiac diseases with an estimated life expectancy of < 2 years, such as malignant tumors, leukemia, etc.; (6) Active bleeding, bleeding disorder, irreversible coagulation dysfunction, severe hepatic dysfunction (Child-Pugh grade C), severe renal dysfunction (eGFR < 30 ml/min/1.73m2); (7) Females of childbearing potential or lactation; (8) Those who are allergic to iodine contrast medium or adenosine and do not apply adenosine; (9) Patients with incomplete clinical data or refusal to give written informed consent.

Design outcomes

Primary

MeasureTime frame
Hyper-QRS ECG;Index of Microcirculatory Resistance,IMR;sensitivity;Specificity;Area under the ROC curve;

Secondary

MeasureTime frame
Positive likelihood ratio;Negative likelihood ratio;Yoden Index;

Countries

China

Contacts

Public ContactJianyuan Pan

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

eypanjianyuan@sina.com+86 180 5654 5697

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026