Observational prospective study to evaluate clinical significance of coronary artery spasm in patients with cardiovascular disease

Observational prospective study to evaluate clinical significance of coronary artery spasm in patients with cardiovascular disease - Clinical investigation of coronary artery spasm in cardiovascular disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058137

Enrollment

1400

Registered

2025-06-15

Start date

2005-10-01

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

Cardiovascular disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients hospitalized at Yamanashi University Hospital who meet all of the following criteria will be included: 1. Diagnosis of ischemic heart disease (angina pectoris or myocardial infarction) or heart failure 2. Underwent intracoronary acetylcholine provocation testing during hospitalization 3. Had blood biochemical tests performed during the hospital stay

Exclusion criteria

Exclusion criteria: The following cases will be excluded from the analysis: 1. Patients undergoing hemodialysis 2. Patients with malignant diseases 3. Patients with severe infections

Design outcomes

Primary

Measure	Time frame
We will evaluate the following outcomes at 5 and 10 years after intracoronary acetylcholine provocation testing: 1. All-cause mortality 2. Cardiovascular death 3. Hospitalization for heart failure 4. Stroke 5. Coronary revascularization 6. Other surgical procedures 7. Other non-cardiac surgical interventions	—

Secondary

Measure	Time frame
We will investigate the association between coronary reactivity to intracoronary acetylcholine provocation and clinical as well as biochemical factors. The following variables will be evaluated: 1. Clinical factors: Age, sex, body mass index (BMI), smoking status, hypertension, diabetes mellitus, dyslipidemia, history of cardiovascular disease, family history of cardiovascular disease, and current medications. 2. Biochemical factors: Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 (ApoA1), apolipoprotein A2 (ApoA2), apolipoprotein C2 (ApoC2), apolipoprotein C3 (ApoC3), apolipoprotein E (ApoE), remnant-like particle cholesterol (RLP-C), free fatty acids (FFA), glucose, immunoreactive insulin (IRI), hemoglobin A1c (HbA1c), C-reactive protein (CRP), and fibrinogen.	—

Measure

Time frame

We will investigate the association between coronary reactivity to intracoronary acetylcholine provocation and clinical as well as biochemical factors. The following variables will be evaluated: 1. Clinical factors: Age, sex, body mass index (BMI), smoking status, hypertension, diabetes mellitus, dyslipidemia, history of cardiovascular disease, family history of cardiovascular disease, and current medications. 2. Biochemical factors: Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 (ApoA1), apolipoprotein A2 (ApoA2), apolipoprotein C2 (ApoC2), apolipoprotein C3 (ApoC3), apolipoprotein E (ApoE), remnant-like particle cholesterol (RLP-C), free fatty acids (FFA), glucose, immunoreactive insulin (IRI), hemoglobin A1c (HbA1c), C-reactive protein (CRP), and fibrinogen.

—

Countries

Japan

Contacts

Public ContactTakamitsu Nakamura

University of Yamanashi Hospital Cardiovascular medicine

takanaka@yamanashi.ac.jp055-273-9590

Outcome results